Drug Safety Alliance
Description
Address: 5003 S Miami Blvd #500, Durham, NC 27703 Phone: (919) 401-8003: Place name: : Website: : Category: : : : Hours: Website: https://www.ashfieldhealthcare.com/en/news/dsa-is-ashfield-pharmacovigilance/ Category: Business management consultant Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?Add missing informationAdd business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Drug Safety Alliance Posting publicly on the Web Write a review Reviews Be the first to review
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Drug Safety Alliance Employees
Employee
Years
Job
Industry
Gwyndolyn Carver Gwyndolyn Carver's Drug Safety Alliance Experience October 2012 - December 2012
Job Clinical Safety Professional
Industry Pharmaceuticals
Experience
Drug Safety Alliance Ashfield Pharmacovigilance May 2015 - Present
PPD December 2014 - April 2015
Theorem Clinical Research August 2014 - November 2014
Drug Safety Alliance, Inc. October 2013 - August 2014
Duke University Medical Center - Duke Cancer Institute December 2012 - March 2013
Drug Safety Alliance October 2012 - December 2012
Quintiles November 2011 - June 2012
Independent Contractor August 2010 - November 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" February 2009 - February 2010
Health Decisions April 2008 - December 2008
Skills
Drug Safety, Clinical Monitoring, CRO, Clinical Trials, EDC, GCP, Inform, Oncology, FDA, Clinical Research, Protocol, Data Management, SOP, MedDRA, CTMS
Education
North Carolina Agricultural and Technical State University 1989 — 1995
Bachelor of Science (B.Sc.), Food Science
Drug Safety Alliance Ashfield Pharmacovigilance May 2015 - Present
PPD December 2014 - April 2015
Theorem Clinical Research August 2014 - November 2014
Drug Safety Alliance, Inc. October 2013 - August 2014
Duke University Medical Center - Duke Cancer Institute December 2012 - March 2013
Drug Safety Alliance October 2012 - December 2012
Quintiles November 2011 - June 2012
Independent Contractor August 2010 - November 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" February 2009 - February 2010
Health Decisions April 2008 - December 2008
Skills
Drug Safety, Clinical Monitoring, CRO, Clinical Trials, EDC, GCP, Inform, Oncology, FDA, Clinical Research, Protocol, Data Management, SOP, MedDRA, CTMS
Education
North Carolina Agricultural and Technical State University 1989 — 1995
Bachelor of Science (B.Sc.), Food Science
Elizabeth Garrard Elizabeth Garrard's Drug Safety Alliance Experience October 2000 - September 2012
Job Senior Director, Safety Risk Management at United Therapeutics
Industry Pharmaceuticals
Experience
United Therapeutics September 2013 - Present
Deloitte March 2013 - September 2013
Garrard Safety Solutions September 2012 - March 2013
Drug Safety Alliance October 2000 - September 2012
Glaxo Wellcome January 1994 - October 2000
GlaxoWellcome / Burroughs Wellcome 1996 - 2000
GlaxoSmithKline 1996 - 2000
Skills
Pharmacovigilance, Oncology, Clinical Research, Drug Safety, Clinical Trials, Regulatory Affairs, CRO, GCP, Pharmaceutical Industry, Sop, FDA, Quality Management, Biotechnology, Lifesciences, Medicine, Healthcare, Validation, Medical Writing, Pharmaceutics, 21 CFR Part 11, CTMS, Computer System..., ICH-GCP, Regulatory Submissions, Medical Affairs, Clinical Data Management, EDC, Life Sciences, Infectious Diseases, Therapeutic Areas, SOP
Education
University of North Carolina at Chapel Hill 1996 — 2000
PharmD, Pharmacy
University of North Carolina at Chapel Hill 1973 — 1978
Doctor of Pharmacy (Pharm.D.), Pharmacy
United Therapeutics September 2013 - Present
Deloitte March 2013 - September 2013
Garrard Safety Solutions September 2012 - March 2013
Drug Safety Alliance October 2000 - September 2012
Glaxo Wellcome January 1994 - October 2000
GlaxoWellcome / Burroughs Wellcome 1996 - 2000
GlaxoSmithKline 1996 - 2000
Skills
Pharmacovigilance, Oncology, Clinical Research, Drug Safety, Clinical Trials, Regulatory Affairs, CRO, GCP, Pharmaceutical Industry, Sop, FDA, Quality Management, Biotechnology, Lifesciences, Medicine, Healthcare, Validation, Medical Writing, Pharmaceutics, 21 CFR Part 11, CTMS, Computer System..., ICH-GCP, Regulatory Submissions, Medical Affairs, Clinical Data Management, EDC, Life Sciences, Infectious Diseases, Therapeutic Areas, SOP
Education
University of North Carolina at Chapel Hill 1996 — 2000
PharmD, Pharmacy
University of North Carolina at Chapel Hill 1973 — 1978
Doctor of Pharmacy (Pharm.D.), Pharmacy
Norina Cowles, CMC Norina Cowles, CMC's Drug Safety Alliance Experience May 2011 - December 2012
Job Ashfield Pharmacovigilance
Industry Pharmaceuticals
Experience
Ashfield Pharmacovigilance April 2015 - Present
Drug Safety Alliance, Inc. January 2013 - March 2015
Drug Safety Alliance May 2011 - December 2012
Drug Safety Alliance July 2010 - April 2011
Drug Safety Alliance February 2008 - July 2010
Drug Safety Alliance December 2005 - February 2008
Drug Safety Alliance July 2005 - December 2005
Skills
Clinical Research, Case Managment, Pharmacovigilance, GCP, Regulatory Affairs, FDA, Sop, MedDRA, Microsoft Office, Healthcare, Pharmaceutical Industry, Microsoft Word, Staff Development, Quality Assurance, Drug Safety, Medical Devices, Regulatory Submissions, Cpr Certified, Data Management, E2B, ICH-GCP, Case Management, SOP, Clinical Trials
Education
Durham Technical Community College 2006 — 2012
Nursing
Washington State University 1998 — 1999
Kinesiology
Ashfield Pharmacovigilance April 2015 - Present
Drug Safety Alliance, Inc. January 2013 - March 2015
Drug Safety Alliance May 2011 - December 2012
Drug Safety Alliance July 2010 - April 2011
Drug Safety Alliance February 2008 - July 2010
Drug Safety Alliance December 2005 - February 2008
Drug Safety Alliance July 2005 - December 2005
Skills
Clinical Research, Case Managment, Pharmacovigilance, GCP, Regulatory Affairs, FDA, Sop, MedDRA, Microsoft Office, Healthcare, Pharmaceutical Industry, Microsoft Word, Staff Development, Quality Assurance, Drug Safety, Medical Devices, Regulatory Submissions, Cpr Certified, Data Management, E2B, ICH-GCP, Case Management, SOP, Clinical Trials
Education
Durham Technical Community College 2006 — 2012
Nursing
Washington State University 1998 — 1999
Kinesiology
Martha Reed Martha Reed's Drug Safety Alliance Experience March 2011 - Present
Job Office Manager at Drug Safety Alliance, Inc. | Part of the Ashfield Division
Industry Pharmaceuticals
Experience
Drug Safety Alliance March 2011 - Present
Talecris Plasma Resources now Grifols December 2006 - April 2008
Duke University February 1998 - June 2006
Skills
Human Resources, Payroll, Recruiting, Management, Budgets, Benefits Administration, Onboarding, Employee Benefits, Employee Relations, HRIS, Deferred Compensation, Performance Management, Talent Management, Personnel Management, Talent Acquisition, Human Resources,...
Education
Strayer University 2002 — 2013
Business Administration/Human Resousrces, Business Management along with Human resousrces, Senior
Keystone Technical Institute 1971 — 1973
AAS, Business Administration and Secretary Science, 3.2
Nether Providence High School 1966 — 1971
High School Diploma, Business
Drug Safety Alliance March 2011 - Present
Talecris Plasma Resources now Grifols December 2006 - April 2008
Duke University February 1998 - June 2006
Skills
Human Resources, Payroll, Recruiting, Management, Budgets, Benefits Administration, Onboarding, Employee Benefits, Employee Relations, HRIS, Deferred Compensation, Performance Management, Talent Management, Personnel Management, Talent Acquisition, Human Resources,...
Education
Strayer University 2002 — 2013
Business Administration/Human Resousrces, Business Management along with Human resousrces, Senior
Keystone Technical Institute 1971 — 1973
AAS, Business Administration and Secretary Science, 3.2
Nether Providence High School 1966 — 1971
High School Diploma, Business
Blake Jackson Blake Jackson's Drug Safety Alliance Experience November 2011 - June 2013
Job President and CEO at Finquest Corporation
Industry Financial Services
Experience
Finquest Corporation June 2013 - Present
Drug Safety Alliance November 2011 - June 2013
Drug Safety Alliance March 2011 - November 2011
Shared Access September 2007 - March 2011
Tekelec July 2005 - August 2007
Spectrasite 2001 - 2005
Dancik International 1997 - 2001
Skills
Strategic Financial..., Forecasting, Revenue Recognition, Sarbanes-Oxley Act, Mergers & Acquisitions, Finance, Budgets, Financial Analysis, Analysis, Project Management, Process Improvement, Financial Reporting, Variance Analysis, Financial Modeling, Managerial Finance, Consolidation, Internal Controls, Financial Planning
Education
Indiana University - Kelley School of Business 2004 — 2007
M.S., Finance
Ithaca College 1992 — 1995
B.S., Finance
Alfred State College - SUNY College of Technology 1990 — 1992
Associate’s Degree, Banking and Financial Services
Finquest Corporation June 2013 - Present
Drug Safety Alliance November 2011 - June 2013
Drug Safety Alliance March 2011 - November 2011
Shared Access September 2007 - March 2011
Tekelec July 2005 - August 2007
Spectrasite 2001 - 2005
Dancik International 1997 - 2001
Skills
Strategic Financial..., Forecasting, Revenue Recognition, Sarbanes-Oxley Act, Mergers & Acquisitions, Finance, Budgets, Financial Analysis, Analysis, Project Management, Process Improvement, Financial Reporting, Variance Analysis, Financial Modeling, Managerial Finance, Consolidation, Internal Controls, Financial Planning
Education
Indiana University - Kelley School of Business 2004 — 2007
M.S., Finance
Ithaca College 1992 — 1995
B.S., Finance
Alfred State College - SUNY College of Technology 1990 — 1992
Associate’s Degree, Banking and Financial Services
William Davis William Davis's Drug Safety Alliance Experience November 2012 - April 2014
Job Customer Delivery Manager at Quintiles
Industry Pharmaceuticals
Experience
Quintiles December 2014 - Present
Drug Safety Alliance, Inc. April 2014 - November 2014
Drug Safety Alliance November 2012 - April 2014
Drug Safety Alliance December 2009 - November 2012
University of North Carolina Hospital at Chapel Hill 2008 - 2009
Black Hills Life Flight 1990 - 2008
Skills
Management, Strategic Planning, Pharmacovigilance, Pharmaceutical Industry, Auditing, Clinical Trials, Oncology, Regulatory Affairs, Biotechnology, Clinical Development, Nursing, Clinical Research, Sop, FDA, Diabetes, Lifesciences, Medical Devices, Cardiology, Project Management, CRO, GCP, Healthcare, Life Sciences, SOP
Education
South Dakota State University
BSN / Science, Nursing and applied sciences
University of Iowa 1988 — 1990
NR Paramedic
Quintiles December 2014 - Present
Drug Safety Alliance, Inc. April 2014 - November 2014
Drug Safety Alliance November 2012 - April 2014
Drug Safety Alliance December 2009 - November 2012
University of North Carolina Hospital at Chapel Hill 2008 - 2009
Black Hills Life Flight 1990 - 2008
Skills
Management, Strategic Planning, Pharmacovigilance, Pharmaceutical Industry, Auditing, Clinical Trials, Oncology, Regulatory Affairs, Biotechnology, Clinical Development, Nursing, Clinical Research, Sop, FDA, Diabetes, Lifesciences, Medical Devices, Cardiology, Project Management, CRO, GCP, Healthcare, Life Sciences, SOP
Education
South Dakota State University
BSN / Science, Nursing and applied sciences
University of Iowa 1988 — 1990
NR Paramedic
Mandi (Enoch) Brantly Mandi (Enoch) Brantly's Drug Safety Alliance Experience March 2012 - May 2012
Job Safety Manager at Novella Clinical
Industry Pharmaceuticals
Experience
Novella Clinical August 2015 - Present
United Therapeutics December 2013 - August 2015
Clinipace Worldwide May 2012 - December 2013
Drug Safety Alliance March 2012 - May 2012
Drug Safety Alliance, Inc., a United Drug Company July 2011 - February 2012
Drug Safety Alliance, Inc., a United Drug Company March 2011 - July 2011
Drug Safety Alliance, Inc., a United Drug Company August 2009 - March 2011
Quintiles July 2008 - August 2009
PPD February 2007 - July 2008
PPD August 2005 - February 2007
Skills
Pharmaceutical Industry, Clinical Trials, Oncology, Diabetes, Pharmacovigilance, CRO, GCP, CTMS, EDC, Therapeutic Areas, ICH-GCP, Biotechnology, Pharmaceutics, Clinical Research, 21 CFR Part 11, Inform, Medical Affairs, Regulatory Requirements, Drug Safety, MedDRA, Clinical Operations, Clinical Development, Clinical Monitoring, FDA, Pharmacology
Education
Campbell University 1999 — 2003
Bachelor of Science (B.S.), Pharmaceutical Sciences
Novella Clinical August 2015 - Present
United Therapeutics December 2013 - August 2015
Clinipace Worldwide May 2012 - December 2013
Drug Safety Alliance March 2012 - May 2012
Drug Safety Alliance, Inc., a United Drug Company July 2011 - February 2012
Drug Safety Alliance, Inc., a United Drug Company March 2011 - July 2011
Drug Safety Alliance, Inc., a United Drug Company August 2009 - March 2011
Quintiles July 2008 - August 2009
PPD February 2007 - July 2008
PPD August 2005 - February 2007
Skills
Pharmaceutical Industry, Clinical Trials, Oncology, Diabetes, Pharmacovigilance, CRO, GCP, CTMS, EDC, Therapeutic Areas, ICH-GCP, Biotechnology, Pharmaceutics, Clinical Research, 21 CFR Part 11, Inform, Medical Affairs, Regulatory Requirements, Drug Safety, MedDRA, Clinical Operations, Clinical Development, Clinical Monitoring, FDA, Pharmacology
Education
Campbell University 1999 — 2003
Bachelor of Science (B.S.), Pharmaceutical Sciences
Tracy Vitti, CQA Tracy Vitti, CQA's Drug Safety Alliance Experience July 2011 - April 2012
Job Associate Director, Global Quality & Compliance Operations at PPD
Industry Pharmaceuticals
Experience
PPD April 2014 - Present
PPD February 2012 - March 2014
Drug Safety Alliance July 2011 - April 2012
Drug Safety Alliance December 2010 - June 2011
Gilead Sciences October 2008 - December 2010
Talecris Biotherapeutics June 2007 - October 2008
Pfizer July 2004 - June 2007
Pfizer December 2001 - July 2004
Pfizer 2004 - 2004
LabCorp 2001 - 2001
Skills
FDA, Quality Assurance, Validation, CAPA, 21 CFR Part 11, Quality Management, Regulatory Affairs, Quality System, GLP, Biotechnology, Document Management, Compliance, Quality Auditing, Process Improvement, SOP, Pharmacovigilance, Audit Management, Regulatory Compliance, CAPA Management, Change Control, Quality Control, CRO
Education
Temple University 2003 — 2017
MS, Quality Assurance / Regulatory Affairs
University of Connecticut 1989 — 1993
BA, Biological Sciences
PPD April 2014 - Present
PPD February 2012 - March 2014
Drug Safety Alliance July 2011 - April 2012
Drug Safety Alliance December 2010 - June 2011
Gilead Sciences October 2008 - December 2010
Talecris Biotherapeutics June 2007 - October 2008
Pfizer July 2004 - June 2007
Pfizer December 2001 - July 2004
Pfizer 2004 - 2004
LabCorp 2001 - 2001
Skills
FDA, Quality Assurance, Validation, CAPA, 21 CFR Part 11, Quality Management, Regulatory Affairs, Quality System, GLP, Biotechnology, Document Management, Compliance, Quality Auditing, Process Improvement, SOP, Pharmacovigilance, Audit Management, Regulatory Compliance, CAPA Management, Change Control, Quality Control, CRO
Education
Temple University 2003 — 2017
MS, Quality Assurance / Regulatory Affairs
University of Connecticut 1989 — 1993
BA, Biological Sciences
Kathleen Fleming Kathleen Fleming's Drug Safety Alliance Experience October 2010 - June 2011
Job I love my job! You could too. Ask me how!
Industry Human Resources
Experience
Purdue Pharma February 2015 - Present
M K Fleming September 1999 - Present
North Carolina Sustainable Energy Association July 2011 - November 2014
Drug Safety Alliance October 2010 - June 2011
Coty July 2009 - October 2010
Talecris Biotherapeutics June 2005 - July 2009
Bayer Biological Products January 2004 - April 2005
Bayer Biological Products 2002 - 2004
Bayer Biological Producs January 2001 - December 2001
Bayer HealthCare December 1999 - February 2001
Skills
Talent Acquisition, Human Resources, Onboarding, Interviews, Sourcing, Applicant Tracking..., Leadership, Personnel Management, Strategy, Temporary Placement, Negotiation, Biotechnology, Workforce Planning, Mergers & Acquisitions, HR Consulting, Strategic Planning, Hiring, Executive Search, Employment Law, Contract Management, Outsourcing, Business Development, Technical Recruiting, CRM, Metrics, HRIS, Mergers, College Recruiting, Healthcare Information..., Passive Sourcing, Boolean Searching, Staffing Industry, Strategic Sourcing, Engineering Placement, FInance Placement, Global Talent..., Pharmaceutical Placement, Biotechnology Placement, Manufacturing Placement, HR Generalist, HR Business Partner, Contract Recruitment, Remote Recruitment, Virtual Recruitment, Recruitment, Clinical Recruitment, Professional Search, OFCCP Expertise, Senior Recruiter, Recruiting
Education
East Carolina University
Bachelor's Degree, Education and Psychology, 3.85
Purdue Pharma February 2015 - Present
M K Fleming September 1999 - Present
North Carolina Sustainable Energy Association July 2011 - November 2014
Drug Safety Alliance October 2010 - June 2011
Coty July 2009 - October 2010
Talecris Biotherapeutics June 2005 - July 2009
Bayer Biological Products January 2004 - April 2005
Bayer Biological Products 2002 - 2004
Bayer Biological Producs January 2001 - December 2001
Bayer HealthCare December 1999 - February 2001
Skills
Talent Acquisition, Human Resources, Onboarding, Interviews, Sourcing, Applicant Tracking..., Leadership, Personnel Management, Strategy, Temporary Placement, Negotiation, Biotechnology, Workforce Planning, Mergers & Acquisitions, HR Consulting, Strategic Planning, Hiring, Executive Search, Employment Law, Contract Management, Outsourcing, Business Development, Technical Recruiting, CRM, Metrics, HRIS, Mergers, College Recruiting, Healthcare Information..., Passive Sourcing, Boolean Searching, Staffing Industry, Strategic Sourcing, Engineering Placement, FInance Placement, Global Talent..., Pharmaceutical Placement, Biotechnology Placement, Manufacturing Placement, HR Generalist, HR Business Partner, Contract Recruitment, Remote Recruitment, Virtual Recruitment, Recruitment, Clinical Recruitment, Professional Search, OFCCP Expertise, Senior Recruiter, Recruiting
Education
East Carolina University
Bachelor's Degree, Education and Psychology, 3.85
Alice MacGregor Alice MacGregor's Drug Safety Alliance Experience June 2009 - March 2011
Job Senior Pharmacovigilance Support Specialist
Industry Pharmaceuticals
Experience
MedImmune May 2014 - Present
Drug Safety Alliance June 2009 - March 2011
Rx INNOVATIONS June 2008 - October 2008
Coldwell Banker Residential Brokerage February 2003 - June 2006
FDA January 1991 - January 1994
St. Elizabeth's hospital, Washington DC May 1989 - September 1991
PEOPLE'S DRUG STORE January 1988 - January 1989
George Washington University 1988 - 1989
Skills
Clinical Trials, FDA
Education
University of Rhode Island
Bachelor of Science, Pharmacy
MedImmune May 2014 - Present
Drug Safety Alliance June 2009 - March 2011
Rx INNOVATIONS June 2008 - October 2008
Coldwell Banker Residential Brokerage February 2003 - June 2006
FDA January 1991 - January 1994
St. Elizabeth's hospital, Washington DC May 1989 - September 1991
PEOPLE'S DRUG STORE January 1988 - January 1989
George Washington University 1988 - 1989
Skills
Clinical Trials, FDA
Education
University of Rhode Island
Bachelor of Science, Pharmacy
Libbie McKenzie Libbie McKenzie's Drug Safety Alliance Experience October 2005 - May 2007
Job Medical Director at Quintiles
Industry Medical Practice
Experience
Quntiles 2007 - Present
Quintiles June 2007 - April 2010
Drug Safety Alliance October 2005 - May 2007
Skills
CRO, Medical Education, Science, Translational Research, Infectious Diseases, Clinical Trials, Oncology, ICH-GCP, Pharmaceutical Industry, Research, Drug Development, Medical Writing, Clinical Research
Education
Duke University School of Medicine 2000 — 2005
Postgraduate Medical Training, Internal Medicine, Nephrology
Duke University School of Medicine 1995 — 1999
MD, Medicine
Duke University 1991 — 1995
BS, Biology, Psychology, Women's Studies
Quntiles 2007 - Present
Quintiles June 2007 - April 2010
Drug Safety Alliance October 2005 - May 2007
Skills
CRO, Medical Education, Science, Translational Research, Infectious Diseases, Clinical Trials, Oncology, ICH-GCP, Pharmaceutical Industry, Research, Drug Development, Medical Writing, Clinical Research
Education
Duke University School of Medicine 2000 — 2005
Postgraduate Medical Training, Internal Medicine, Nephrology
Duke University School of Medicine 1995 — 1999
MD, Medicine
Duke University 1991 — 1995
BS, Biology, Psychology, Women's Studies
Douglas Hill Douglas Hill's Drug Safety Alliance Experience October 2007 - July 2011
Job US Vice President and CIO at Foresight Group International, AG
Industry Pharmaceuticals
Experience
Foresight Group International, AG 2011 - Present
Drug Safety Alliance October 2007 - July 2011
The Hill Consulting Group March 2005 - December 2007
Technology Consulting Associates January 2001 - March 2005
MSA PASS January 1996 - December 2000
Pittsburgh Corning Corporation 1989 - 1995
Skills
21 CFR Part 11, SDLC, Computer System..., Software Documentation, Pharmacovigilance, Pharmaceutical Industry, Integration, Project Management, Business Intelligence, Databases, Sop, Drug Safety, IT Management, ETL, IT Strategy, Requirements Analysis, Requirements Gathering, CRO, Validation, Oracle, Software Development, Testing, Data Management, Information Technology, Database Design, Clinical Trials, Drug Safety System..., Software Development..., Data Warehousing, Strategy, FDA, Change Control, Management, Clinical Development, Drug Safety Systems:..., Drug Safety Data..., IT Project Management, Standard Operating..., Programming Languages:..., Quality Assurance, CTMS, Lifesciences, Clinical Data Management, GxP, EDC, Business Process, Vendor Management, Data Migration, IT Infrastructure, Audit Preparation
Education
University of Pittsburgh
BS, Computer Science
Foresight Group International, AG 2011 - Present
Drug Safety Alliance October 2007 - July 2011
The Hill Consulting Group March 2005 - December 2007
Technology Consulting Associates January 2001 - March 2005
MSA PASS January 1996 - December 2000
Pittsburgh Corning Corporation 1989 - 1995
Skills
21 CFR Part 11, SDLC, Computer System..., Software Documentation, Pharmacovigilance, Pharmaceutical Industry, Integration, Project Management, Business Intelligence, Databases, Sop, Drug Safety, IT Management, ETL, IT Strategy, Requirements Analysis, Requirements Gathering, CRO, Validation, Oracle, Software Development, Testing, Data Management, Information Technology, Database Design, Clinical Trials, Drug Safety System..., Software Development..., Data Warehousing, Strategy, FDA, Change Control, Management, Clinical Development, Drug Safety Systems:..., Drug Safety Data..., IT Project Management, Standard Operating..., Programming Languages:..., Quality Assurance, CTMS, Lifesciences, Clinical Data Management, GxP, EDC, Business Process, Vendor Management, Data Migration, IT Infrastructure, Audit Preparation
Education
University of Pittsburgh
BS, Computer Science
Rosalind Clements Rosalind Clements's Drug Safety Alliance Experience 2006 - 2010
Job
Industry Individual & Family Services
Experience
MAG DS Corp December 2013 - Present
Drug Safety Alliance 2006 - 2010
Mylan Bertek Pharmaceuticals 2001 - 2005
GlaxoSmithKline 1992 - 2001
Skills
Youth Leadership, Team-oriented, Event Planning, Time Management, Highly Detailed, Strategic Planning, Management, Organization &..., Research, Employee Benefits, Recruiting, Leadership, Coaching, Human Resources, Training, Healthcare, Employee Relations
Education
Strayer University 2014 — 2016
Bachelor of Business Administration (B.B.A.), Human Resources Management and Services
Durham Technical Community College 2010 — 2012
Associate of Arts (AA), Education
MAG DS Corp December 2013 - Present
Drug Safety Alliance 2006 - 2010
Mylan Bertek Pharmaceuticals 2001 - 2005
GlaxoSmithKline 1992 - 2001
Skills
Youth Leadership, Team-oriented, Event Planning, Time Management, Highly Detailed, Strategic Planning, Management, Organization &..., Research, Employee Benefits, Recruiting, Leadership, Coaching, Human Resources, Training, Healthcare, Employee Relations
Education
Strayer University 2014 — 2016
Bachelor of Business Administration (B.B.A.), Human Resources Management and Services
Durham Technical Community College 2010 — 2012
Associate of Arts (AA), Education
Dan Serany Dan Serany's Drug Safety Alliance Experience June 2010 - July 2011
Job Director, Customer Engagement Management at Genesys
Industry Computer Software
Experience
Genesys March 2014 - Present
Genesys Echopass November 2013 - March 2014
Echopass 2011 - 2013
Drug Safety Alliance June 2010 - July 2011
Drug Safety Alliance July 2010 - May 2011
GlaxoSmithKline July 1989 - June 2010
Skills
Sop, Pharmacovigilance, Project Management, CRM, Biotechnology, SaaS, Change Management, Quality Assurance, Strategy, Call Center, Integration, Strategic Planning, Cloud Computing, Pharmaceutical Industry, Program Management, Training, Management, Call Centers, Cross-functional Team..., Process Improvement, Business Analysis, Leadership, PMP, Medical Devices, Sales, Business Process..., Product Management, Vendor Management, Professional Services
Education
North Carolina Wesleyan College
BS, Business Administration
Penn State University
AAS, Electrical Engineering Technology
Genesys March 2014 - Present
Genesys Echopass November 2013 - March 2014
Echopass 2011 - 2013
Drug Safety Alliance June 2010 - July 2011
Drug Safety Alliance July 2010 - May 2011
GlaxoSmithKline July 1989 - June 2010
Skills
Sop, Pharmacovigilance, Project Management, CRM, Biotechnology, SaaS, Change Management, Quality Assurance, Strategy, Call Center, Integration, Strategic Planning, Cloud Computing, Pharmaceutical Industry, Program Management, Training, Management, Call Centers, Cross-functional Team..., Process Improvement, Business Analysis, Leadership, PMP, Medical Devices, Sales, Business Process..., Product Management, Vendor Management, Professional Services
Education
North Carolina Wesleyan College
BS, Business Administration
Penn State University
AAS, Electrical Engineering Technology
Deena Wegner Deena Wegner's Drug Safety Alliance Experience May 2008 - July 2009
Job VicePresident of Business Operations and CoFounder at Drug Safety Navigator LLC
Industry Management Consulting
Experience
Drug Safety Navigator, LLC December 2011 - Present
Infinity Systems, Inc. August 2009 - Present
Drug Safety Alliance May 2008 - July 2009
BioPharma Consultants June 2007 - April 2008
RTI International February 2006 - May 2007
Integrated Safety Systems, Inc. August 2004 - February 2006
Berlex Laboratories December 1980 - April 2004
Skills
Business Development, Critical Thinking, Business Plan &..., Sales Skills Training, Sales management &..., Niche CRO Business..., Selling Skills, Sales Management, Niche Marketing, Marketing, Coaching, Business Planning, CRO, Business, Strategy, Pharmacovigilance, Pharmaceutical Industry
Education
Tulane University 1974 — 1978
B.S.
North Carolina State University 2010 — 2010
Certification
Drug Safety Navigator, LLC December 2011 - Present
Infinity Systems, Inc. August 2009 - Present
Drug Safety Alliance May 2008 - July 2009
BioPharma Consultants June 2007 - April 2008
RTI International February 2006 - May 2007
Integrated Safety Systems, Inc. August 2004 - February 2006
Berlex Laboratories December 1980 - April 2004
Skills
Business Development, Critical Thinking, Business Plan &..., Sales Skills Training, Sales management &..., Niche CRO Business..., Selling Skills, Sales Management, Niche Marketing, Marketing, Coaching, Business Planning, CRO, Business, Strategy, Pharmacovigilance, Pharmaceutical Industry
Education
Tulane University 1974 — 1978
B.S.
North Carolina State University 2010 — 2010
Certification
Bonnie Whitehead's Drug Safety Alliance Experience October 2012 - December 2012
Job Regulatory and Start Up Specialist at Quintiles Transnational
Industry Pharmaceuticals
Experience
PAREXEL July 2014 - February 2015
PPD January 2014 - July 2014
Step Up Ministry July 2011 - December 2013
Drug Safety Alliance October 2012 - December 2012
Quintiles November 2011 - April 2012
Polaris Compliance Consultants, Inc February 2011 - February 2011
BioCryst Pharmaceuticals Inc November 2009 - April 2010
Purdue University August 2006 - October 2009
GlaxoSmithKline August 2001 - August 2006
Quintiles Transnational December 2000 - March 2001
Skills
Medical Writing, Pharmacovigilance, Research Project..., CTMS, GCP, Clinical Trials, Clinical Development, Therapeutic Areas, Clinical Research, Oncology, Urology, Clinical Monitoring, Medicine, Sop, Lifesciences, Clinical Data Management, Clinical Pharmacology, Project Management, Drug Development, Protocol, Pharmaceutical Industry, CRO, FDA, Pharmacokinetics, IND, Pharmaceutics, Infectious Diseases, Vaccines, Cancer, Biotechnology, Regulatory Affairs, Immunology, GLP, Clinical Study Design, Pharmacology, EDC, Drug Safety, ICH-GCP, Regulatory Submissions, Diabetes, Phase I, Biomarkers, Assay Development, SOP
Education
University of North Carolina at Chapel Hill 1978 — 1979
MAT, Biology
Randolph College
Bachelor of Arts (no BS offered), Biology
PAREXEL July 2014 - February 2015
PPD January 2014 - July 2014
Step Up Ministry July 2011 - December 2013
Drug Safety Alliance October 2012 - December 2012
Quintiles November 2011 - April 2012
Polaris Compliance Consultants, Inc February 2011 - February 2011
BioCryst Pharmaceuticals Inc November 2009 - April 2010
Purdue University August 2006 - October 2009
GlaxoSmithKline August 2001 - August 2006
Quintiles Transnational December 2000 - March 2001
Skills
Medical Writing, Pharmacovigilance, Research Project..., CTMS, GCP, Clinical Trials, Clinical Development, Therapeutic Areas, Clinical Research, Oncology, Urology, Clinical Monitoring, Medicine, Sop, Lifesciences, Clinical Data Management, Clinical Pharmacology, Project Management, Drug Development, Protocol, Pharmaceutical Industry, CRO, FDA, Pharmacokinetics, IND, Pharmaceutics, Infectious Diseases, Vaccines, Cancer, Biotechnology, Regulatory Affairs, Immunology, GLP, Clinical Study Design, Pharmacology, EDC, Drug Safety, ICH-GCP, Regulatory Submissions, Diabetes, Phase I, Biomarkers, Assay Development, SOP
Education
University of North Carolina at Chapel Hill 1978 — 1979
MAT, Biology
Randolph College
Bachelor of Arts (no BS offered), Biology
Lori Murphy Lori Murphy's Drug Safety Alliance Experience January 2005 - August 2006
Job Drug Safety Associate III at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences August 2015 - Present
InterMune May 2012 - July 2015
Gilead Sciences September 2010 - May 2012
Genentech Pharmaceutical May 2010 - September 2010
Duke Comprehensive Cancer Center July 2009 - February 2010
Quintiles, Inc August 2006 - February 2009
Drug Safety Alliance January 2005 - August 2006
Inveresk Research August 2001 - November 2004
Inveresk Research August 2001 - August 2004
Quintiles, Inc February 2000 - August 2001
Skills
FDA, Clinical Research, Clinical Trials, Oncology, CRO, GCP, Pharmacovigilance, Therapeutic Areas, Clinical Data Management, Infectious Diseases, Pharmaceutical Industry, SOP, Clinical Development, CTMS, Drug Safety, Biotechnology
Education
University of North Carolina at Chapel Hill
BSN, Nursing
PRA Health Sciences August 2015 - Present
InterMune May 2012 - July 2015
Gilead Sciences September 2010 - May 2012
Genentech Pharmaceutical May 2010 - September 2010
Duke Comprehensive Cancer Center July 2009 - February 2010
Quintiles, Inc August 2006 - February 2009
Drug Safety Alliance January 2005 - August 2006
Inveresk Research August 2001 - November 2004
Inveresk Research August 2001 - August 2004
Quintiles, Inc February 2000 - August 2001
Skills
FDA, Clinical Research, Clinical Trials, Oncology, CRO, GCP, Pharmacovigilance, Therapeutic Areas, Clinical Data Management, Infectious Diseases, Pharmaceutical Industry, SOP, Clinical Development, CTMS, Drug Safety, Biotechnology
Education
University of North Carolina at Chapel Hill
BSN, Nursing
Ted Glod Ted Glod's Drug Safety Alliance Experience February 2011 - June 2014
Job Sr. Director Audit, Quality and Regulatory Compliance at Drug Safety Alliance | Ashfield Pharmacovigilance
Industry Pharmaceuticals
Experience
Ashfield Pharmacovigilance June 2014 - Present
Drug Safety Alliance February 2011 - June 2014
Gilead Sciences March 2008 - December 2010
Gilead Sciences 2004 - March 2008
Triangle Pharmaceuticals Inc. 2002 - 2004
Traingle Pharmaceuticals Inc. 2000 - 2002
Triangle Pharmaceuticals Inc. May 1998 - 2000
Family Health International January 1996 - May 1998
Burroughs Wellcome Co. 1989 - October 1995
Skills
Validation, 21 CFR Part 11, Computer System..., Change Control, GxP, GCP, Pharmaceutical Industry, FDA, Training, Project Management, Clinical Trials, Biotechnology, Leadership, Auditing, Management, Clinical Development, Regulatory Affairs, CRO, Technology Transfer, Clinical Research, Life Sciences, Software Quality..., Quality Assurance, Sop, GMP, QMS, Regulatory Compliance, Quality System
Education
North Carolina State University
MS, Analytical Chemistry
North Carolina State University
BS, Chemistry
Ashfield Pharmacovigilance June 2014 - Present
Drug Safety Alliance February 2011 - June 2014
Gilead Sciences March 2008 - December 2010
Gilead Sciences 2004 - March 2008
Triangle Pharmaceuticals Inc. 2002 - 2004
Traingle Pharmaceuticals Inc. 2000 - 2002
Triangle Pharmaceuticals Inc. May 1998 - 2000
Family Health International January 1996 - May 1998
Burroughs Wellcome Co. 1989 - October 1995
Skills
Validation, 21 CFR Part 11, Computer System..., Change Control, GxP, GCP, Pharmaceutical Industry, FDA, Training, Project Management, Clinical Trials, Biotechnology, Leadership, Auditing, Management, Clinical Development, Regulatory Affairs, CRO, Technology Transfer, Clinical Research, Life Sciences, Software Quality..., Quality Assurance, Sop, GMP, QMS, Regulatory Compliance, Quality System
Education
North Carolina State University
MS, Analytical Chemistry
North Carolina State University
BS, Chemistry
Marisa del Hierro - Law Marisa del Hierro - Law's Drug Safety Alliance Experience August 2011 - October 2013
Job Director of Regulatory Affairs at Ashfield Pharmacovigilance
Industry Pharmaceuticals
Experience
Ashfield Pharmacovigilance September 2014 - Present
Drug Safety Alliance, Inc. October 2013 - Present
Drug Safety Alliance August 2011 - October 2013
Drug Safety Alliance June 2011 - August 2011
Drug Safety Alliance January 2008 - June 2011
Drug Safety Alliance January 2007 - January 2008
Drug Safety Alliance January 2006 - January 2007
Drug Safety Alliance August 2004 - December 2006
Drug Safety Alliance November 2003 - July 2004
Skills
Pharmacovigilance, Regulatory Affairs, FDA, GCP, CRO, Clinical Development, 21 CFR Part 11, Clinical Trials, Pharmaceutical Industry, Eudravigilance..., XEVMPD Certified, Databases, Data Migration, Argus Safety, Global Regulatory..., ICH-GCP, CTMS, Regulatory Submissions, SOP, Biotechnology, Oncology
Education
Florida Atlantic University 1989 — 1991
BS, Marketing Management
Ashfield Pharmacovigilance September 2014 - Present
Drug Safety Alliance, Inc. October 2013 - Present
Drug Safety Alliance August 2011 - October 2013
Drug Safety Alliance June 2011 - August 2011
Drug Safety Alliance January 2008 - June 2011
Drug Safety Alliance January 2007 - January 2008
Drug Safety Alliance January 2006 - January 2007
Drug Safety Alliance August 2004 - December 2006
Drug Safety Alliance November 2003 - July 2004
Skills
Pharmacovigilance, Regulatory Affairs, FDA, GCP, CRO, Clinical Development, 21 CFR Part 11, Clinical Trials, Pharmaceutical Industry, Eudravigilance..., XEVMPD Certified, Databases, Data Migration, Argus Safety, Global Regulatory..., ICH-GCP, CTMS, Regulatory Submissions, SOP, Biotechnology, Oncology
Education
Florida Atlantic University 1989 — 1991
BS, Marketing Management
Ann Marie Curatolo Ann Marie Curatolo's Drug Safety Alliance Experience June 2012 - April 2013
Job Senior Clinical Research Manager at Medtronic
Industry Medical Devices
Experience
Medtronic Spine & Biologics June 2014 - Present
GTx, Inc. April 2013 - June 2014
Drug Safety Alliance June 2012 - April 2013
Pfizer (Formerly King Pharmaceuticals) August 2009 - June 2012
GSK 2011 - 2012
King Pharmaceuticals November 2009 - January 2011
Ranbaxy 2007 - 2009
Carolinas Healthcare System 2005 - 2007
Skills
Drug Safety, Quality Assurance, Leadership, Neuroscience, Healthcare, Clinical Trials, Pharmaceutical Industry, GCP, Risk Management, Oncology, Regulatory Submissions, Clinical Development, Pharmacovigilance, Regulatory Affairs, Clinical Research, Neurology, CRO, Training, ICH-GCP, FDA
Education
Critical Care Institute CCHS 1999 — 1999
Critical Care Nursing
Centennial College 1996 — 1998
Nursing, Nursing
University of Toronto 1989 — 1996
BScHon, Neuroscience, Biology
Medtronic Spine & Biologics June 2014 - Present
GTx, Inc. April 2013 - June 2014
Drug Safety Alliance June 2012 - April 2013
Pfizer (Formerly King Pharmaceuticals) August 2009 - June 2012
GSK 2011 - 2012
King Pharmaceuticals November 2009 - January 2011
Ranbaxy 2007 - 2009
Carolinas Healthcare System 2005 - 2007
Skills
Drug Safety, Quality Assurance, Leadership, Neuroscience, Healthcare, Clinical Trials, Pharmaceutical Industry, GCP, Risk Management, Oncology, Regulatory Submissions, Clinical Development, Pharmacovigilance, Regulatory Affairs, Clinical Research, Neurology, CRO, Training, ICH-GCP, FDA
Education
Critical Care Institute CCHS 1999 — 1999
Critical Care Nursing
Centennial College 1996 — 1998
Nursing, Nursing
University of Toronto 1989 — 1996
BScHon, Neuroscience, Biology
Tanya Achmetov RN, BSN, CMC Tanya Achmetov RN, BSN, CMC's Drug Safety Alliance Experience March 2012 - July 2012
Job Patient Safety Analyst at UCB Biosciences
Industry Pharmaceuticals
Experience
UCB Biosciences July 2015 - Present
Salix Pharmaceuticals September 2013 - June 2015
Drug Safety Alliance, a United Drug Company July 2012 - September 2013
Drug Safety Alliance March 2012 - July 2012
Pfizer Inc. (King Pharmaceuticals) 2007 - November 2011
PPD 2003 - 2007
University of Virginia Medical Center 2002 - 2003
Skills
MedDRA (Medical..., Argus, Clintrace, Clintrack, Oracle AERS, Infomed, Microsoft Office, Google Apps, GPCMS (Global Product..., Freelance Copywriting /..., Medicine, MedDRA, Complaint Management, Pharmacovigilance, Clinical Trials, Technical Documentation, Drug Safety, Pharmaceutical Industry, Clinical Research, Lifesciences, Biotechnology, 21 CFR Part 11, GCP, Regulatory Submissions, Clinical Development, Regulatory Affairs, Diabetes, Oncology, Life Sciences, CRO
Education
University of Virginia 2000 — 2002
BSN, Nursing
Randolph College 1996 — 2000
BS, Biology
UCB Biosciences July 2015 - Present
Salix Pharmaceuticals September 2013 - June 2015
Drug Safety Alliance, a United Drug Company July 2012 - September 2013
Drug Safety Alliance March 2012 - July 2012
Pfizer Inc. (King Pharmaceuticals) 2007 - November 2011
PPD 2003 - 2007
University of Virginia Medical Center 2002 - 2003
Skills
MedDRA (Medical..., Argus, Clintrace, Clintrack, Oracle AERS, Infomed, Microsoft Office, Google Apps, GPCMS (Global Product..., Freelance Copywriting /..., Medicine, MedDRA, Complaint Management, Pharmacovigilance, Clinical Trials, Technical Documentation, Drug Safety, Pharmaceutical Industry, Clinical Research, Lifesciences, Biotechnology, 21 CFR Part 11, GCP, Regulatory Submissions, Clinical Development, Regulatory Affairs, Diabetes, Oncology, Life Sciences, CRO
Education
University of Virginia 2000 — 2002
BSN, Nursing
Randolph College 1996 — 2000
BS, Biology
Anna Stokes Anna Stokes's Drug Safety Alliance Experience May 2010 - July 2010
Job Account Manager at Comcast
Industry Public Relations and Communications
Experience
Comcast April 2015 - Present
National CineMedia (NCM) March 2014 - April 2015
Insight Global July 2013 - February 2014
The Dalton Agency August 2012 - June 2013
South Carolina Bar January 2013 - May 2013
The People’s Pharmacy July 2012 - August 2012
Haute Hanger May 2011 - July 2011
Drug Safety Alliance May 2010 - July 2010
Vert and Vogue May 2009 - August 2009
Skills
Social Media, Marketing, Trade Shows, Time Management, Customer Service, Press Releases, Public Relations, Media Relations, Social Media Marketing, Facebook, Blogging, Marketing Communications, Advertising, Strategic Communications, Copywriting, Social Networking, Event Planning, Corporate Communications, Editing, Journalism, Crisis Communications
Education
University of South Carolina-Columbia 2009 — 2013
Bachelor of Arts (BA), Communication, Journalism, and Related Programs
The Umbra Institute 2012 — 2012
Durham Academy 1994 — 2009
Comcast April 2015 - Present
National CineMedia (NCM) March 2014 - April 2015
Insight Global July 2013 - February 2014
The Dalton Agency August 2012 - June 2013
South Carolina Bar January 2013 - May 2013
The People’s Pharmacy July 2012 - August 2012
Haute Hanger May 2011 - July 2011
Drug Safety Alliance May 2010 - July 2010
Vert and Vogue May 2009 - August 2009
Skills
Social Media, Marketing, Trade Shows, Time Management, Customer Service, Press Releases, Public Relations, Media Relations, Social Media Marketing, Facebook, Blogging, Marketing Communications, Advertising, Strategic Communications, Copywriting, Social Networking, Event Planning, Corporate Communications, Editing, Journalism, Crisis Communications
Education
University of South Carolina-Columbia 2009 — 2013
Bachelor of Arts (BA), Communication, Journalism, and Related Programs
The Umbra Institute 2012 — 2012
Durham Academy 1994 — 2009
Chad Church's Drug Safety Alliance Experience February 2009 - December 2009
Job PreSales Engineer at Syncfusion
Industry Computer Software
Experience
Syncfusion January 2010 - Present
Drug Safety Alliance February 2009 - December 2009
Centice Inc. February 2007 - February 2009
GSK September 2001 - February 2007
Packard Bioscience September 1999 - September 2001
Tecan US January 1997 - September 1999
Skills
Laboratory Automation, Software Development, Customer Relations, Process Improvement, Pre-sales, SaaS, Business Analysis, Windows, Agile Methodologies, Cloud Computing, Product Management, Sales Operations, Product Development, Sales Process, Enterprise Software, C#, Customer Service, Microsoft SQL Server
Education
North Carolina State University 1991 — 1996
BS, Zoology/Microbiology
Syncfusion January 2010 - Present
Drug Safety Alliance February 2009 - December 2009
Centice Inc. February 2007 - February 2009
GSK September 2001 - February 2007
Packard Bioscience September 1999 - September 2001
Tecan US January 1997 - September 1999
Skills
Laboratory Automation, Software Development, Customer Relations, Process Improvement, Pre-sales, SaaS, Business Analysis, Windows, Agile Methodologies, Cloud Computing, Product Management, Sales Operations, Product Development, Sales Process, Enterprise Software, C#, Customer Service, Microsoft SQL Server
Education
North Carolina State University 1991 — 1996
BS, Zoology/Microbiology
Catherine Donatucci Catherine Donatucci's Drug Safety Alliance Experience June 2010 - August 2010
Job Junior Program Analyst at System Planning Corporation
Industry Research
Experience
System Planning Corporation January 2015 - Present
System Planning Corporation November 2012 - January 2015
Visual Cognition Laboratory at Duke University May 2011 - August 2011
Drug Safety Alliance June 2010 - August 2010
Jones Laboratory for Exercise-Oncology Research at Duke University May 2009 - August 2009
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Social Media, Facebook, Blogging, Data Entry, Database Administration, Data Analysis, Active Top Secret..., PowerPoint, Analysis, Time Management
Education
Elon University 2008 — 2012
Bachelor of Arts, Psychology, 3.643
System Planning Corporation January 2015 - Present
System Planning Corporation November 2012 - January 2015
Visual Cognition Laboratory at Duke University May 2011 - August 2011
Drug Safety Alliance June 2010 - August 2010
Jones Laboratory for Exercise-Oncology Research at Duke University May 2009 - August 2009
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Social Media, Facebook, Blogging, Data Entry, Database Administration, Data Analysis, Active Top Secret..., PowerPoint, Analysis, Time Management
Education
Elon University 2008 — 2012
Bachelor of Arts, Psychology, 3.643
Molly James Molly James's Drug Safety Alliance Experience July 2006 - September 2007
Job Vice President, Global Safety Operations at Drug Safety Navigator, LLC
Industry Pharmaceuticals
Experience
Drug Safety Navigator, LLC January 2015 - Present
Five Oaks Pharm, LLC September 2011 - January 2015
Inspire May 2010 - September 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" January 2009 - May 2010
UCB Pharma 2007 - 2009
Drug Safety Alliance July 2006 - September 2007
PPD 2002 - 2006
Skills
Clinical Trials, CRO, Clinical Research, Pharmacovigilance, ICH-GCP, Drug Safety, EDC, Sop, CTMS, Pharmaceutics, Biotechnology, Regulatory Requirements, Oncology, Clinical Development, GCP, SOP
Education
University of Michigan 1982 — 1986
BSN, Nursing
Drug Safety Navigator, LLC January 2015 - Present
Five Oaks Pharm, LLC September 2011 - January 2015
Inspire May 2010 - September 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" January 2009 - May 2010
UCB Pharma 2007 - 2009
Drug Safety Alliance July 2006 - September 2007
PPD 2002 - 2006
Skills
Clinical Trials, CRO, Clinical Research, Pharmacovigilance, ICH-GCP, Drug Safety, EDC, Sop, CTMS, Pharmaceutics, Biotechnology, Regulatory Requirements, Oncology, Clinical Development, GCP, SOP
Education
University of Michigan 1982 — 1986
BSN, Nursing
Adrian Johnson's Drug Safety Alliance Experience October 2011 - September 2012
Job Pharmacovilance Manager at United Therapeutics
Industry Biotechnology
Experience
United Therapeutics September 2013 - Present
United Therapeutics September 2012 - September 2013
Drug Safety Alliance October 2011 - September 2012
United Therapeutics November 2010 - May 2011
Otsuka America Pharmaceutical, Inc. 2011 - 2011
Abbott Laboratories 2011 - 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" July 2009 - November 2010
Synteract, Inc. 2008 - 2009
Quintiles 2006 - 2008
Duke University August 1998 - 2006
Skills
GCP, Clinical Research, Healthcare, Drug Safety, Clinical Trials, Oncology, CRO, Cardiology, EDC, Pharmacovigilance, Medical Devices, Research, Protocol, Sop, Nursing, Cancer, ICH-GCP, CTMS, Clinical Data Management, Clinical Development, Clinical Monitoring, FDA, Medicine, Pharmaceutical Industry, Regulatory Requirements, Therapeutic Areas, SOP
Education
North Carolina Agricultural and Technical State University
BS, Nursing
United Therapeutics September 2013 - Present
United Therapeutics September 2012 - September 2013
Drug Safety Alliance October 2011 - September 2012
United Therapeutics November 2010 - May 2011
Otsuka America Pharmaceutical, Inc. 2011 - 2011
Abbott Laboratories 2011 - 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" July 2009 - November 2010
Synteract, Inc. 2008 - 2009
Quintiles 2006 - 2008
Duke University August 1998 - 2006
Skills
GCP, Clinical Research, Healthcare, Drug Safety, Clinical Trials, Oncology, CRO, Cardiology, EDC, Pharmacovigilance, Medical Devices, Research, Protocol, Sop, Nursing, Cancer, ICH-GCP, CTMS, Clinical Data Management, Clinical Development, Clinical Monitoring, FDA, Medicine, Pharmaceutical Industry, Regulatory Requirements, Therapeutic Areas, SOP
Education
North Carolina Agricultural and Technical State University
BS, Nursing
Joseph Knight-McKenna Joseph Knight-McKenna's Drug Safety Alliance Experience October 2005 - December 2010
Job Director, Global Head Quality and Training for Lifecycle Safety at Quintiles
Industry Pharmaceuticals
Experience
Quintiles December 2010 - Present
Drug Safety Alliance October 2005 - December 2010
Phase Forward, Inc. July 2003 - July 2005
Phase Forward April 2000 - July 2003
Beth Israel Deaconess Medical Center 1999 - 2000
Astra Pharmaceuticals 1997 - 1999
Education
Bryant University 1998 — 1999
Certificate of Advance Graduate Studies, Health Care Management
The University of the State of New York 1996 — 1998
B.S.N., Nursing
Heriot-Watt University 1995 — 1997
MBA, Business
Cape Cod Community College
ADN, Nursing
Saint John Fisher College
B.A., Communications
Quintiles December 2010 - Present
Drug Safety Alliance October 2005 - December 2010
Phase Forward, Inc. July 2003 - July 2005
Phase Forward April 2000 - July 2003
Beth Israel Deaconess Medical Center 1999 - 2000
Astra Pharmaceuticals 1997 - 1999
Education
Bryant University 1998 — 1999
Certificate of Advance Graduate Studies, Health Care Management
The University of the State of New York 1996 — 1998
B.S.N., Nursing
Heriot-Watt University 1995 — 1997
MBA, Business
Cape Cod Community College
ADN, Nursing
Saint John Fisher College
B.A., Communications
Teresa Wagner Teresa Wagner's Drug Safety Alliance Experience December 2010 - June 2011
Job Manager at Accenture
Industry Pharmaceuticals
Experience
Accenture November 2012 - Present
Aris Global August 2011 - November 2012
Drug Safety Alliance December 2010 - June 2011
Copernicus Group IRB July 2007 - December 2010
PPD, Inc. December 2005 - June 2007
PharmaLinkFHI 1999 - 2005
Skills
Staff Development, Negotiation, Staff Management, Budgeting, Customer Relations, Forecasting, Contract Management, Strategic Planning, Planning, Team Building, Business Planning, Customer Service, Problem Solving, Mentoring, Budgets, Project Planning, Clinical Trials, CRO, Pharmacovigilance, CTMS, Risk Management, Leadership, Project Management, Human Resources, Quality Assurance, GCP, Management, Pharmaceutical Industry
Education
Southern Illinois University, Carbondale 1978 — 1981
BSIE, Industrial Engineering
Community College of the Air Force 1977 — 1978
AAS, Aeronautical Engineering
Jefferson College 1974 — 1976
AFA, Instrumental Music, Elementary Education
Accenture November 2012 - Present
Aris Global August 2011 - November 2012
Drug Safety Alliance December 2010 - June 2011
Copernicus Group IRB July 2007 - December 2010
PPD, Inc. December 2005 - June 2007
PharmaLinkFHI 1999 - 2005
Skills
Staff Development, Negotiation, Staff Management, Budgeting, Customer Relations, Forecasting, Contract Management, Strategic Planning, Planning, Team Building, Business Planning, Customer Service, Problem Solving, Mentoring, Budgets, Project Planning, Clinical Trials, CRO, Pharmacovigilance, CTMS, Risk Management, Leadership, Project Management, Human Resources, Quality Assurance, GCP, Management, Pharmaceutical Industry
Education
Southern Illinois University, Carbondale 1978 — 1981
BSIE, Industrial Engineering
Community College of the Air Force 1977 — 1978
AAS, Aeronautical Engineering
Jefferson College 1974 — 1976
AFA, Instrumental Music, Elementary Education
Aaryn Olesen's Drug Safety Alliance Experience 2006 - 2008
Job Director, Global Patient Safety at AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca February 2014 - Present
MedImmune (an AstraZeneca company) May 2008 - February 2014
Drug Safety Alliance 2006 - 2008
Elan Pharmaceuticals, Inc. 2001 - 2004
Novartis 2000 - 2001
Skills
Pharmacovigilance, Pharmacoepidemiology, Pharmaceutical Industry, Clinical Trials, GCP, Sop, Biotechnology, Compliance, Outcomes Research
Education
UCLA
BA, Psychology (Biology)
University of North Carolina at Chapel Hill
PhD (in progress), Pharmaceutical Policy and Evaluative Sciences (Pharmacoepidemiology)
Yale University School of Medicine
MPH, Health Policy and Management
AstraZeneca February 2014 - Present
MedImmune (an AstraZeneca company) May 2008 - February 2014
Drug Safety Alliance 2006 - 2008
Elan Pharmaceuticals, Inc. 2001 - 2004
Novartis 2000 - 2001
Skills
Pharmacovigilance, Pharmacoepidemiology, Pharmaceutical Industry, Clinical Trials, GCP, Sop, Biotechnology, Compliance, Outcomes Research
Education
UCLA
BA, Psychology (Biology)
University of North Carolina at Chapel Hill
PhD (in progress), Pharmaceutical Policy and Evaluative Sciences (Pharmacoepidemiology)
Yale University School of Medicine
MPH, Health Policy and Management
Susanne Rallis's Drug Safety Alliance Experience November 2010 - April 2012
Job Associate Operations Specialist at Quintiles
Industry Hospital & Health Care
Experience
Quintiles March 2015 - Present
SPRI Clinical Trials September 2014 - Present
Theorem Clinical Research October 2014 - February 2015
DSA November 2013 - July 2014
Drug Safety Alliance November 2010 - April 2012
Drug Safety Alliance December 2009 - April 2010
Dr Cynthia Gregg September 2004 - March 2010
Biolex September 2009 - December 2009
Fresenius Medical Care September 2007 - June 2009
Cary Academy August 1999 - August 2008
Skills
GCP, Drug Safety, Regulatory Affairs, Clinical Trials, Oncology, Pharmaceutical Industry, Clinical Research, Clinical Development, CRO, Case Management, Pharmacovigilance, Healthcare, Leadership
Education
Loyola University New Orleans 2007 — 2009
MSN, Master's of Health Care Systems Management, 4.0
University of North Carolina at Chapel Hill 2005 — 2006
Certificate, Clinical Research Associate
University of North Alabama
BSN, Nursing, 3.8
Quintiles March 2015 - Present
SPRI Clinical Trials September 2014 - Present
Theorem Clinical Research October 2014 - February 2015
DSA November 2013 - July 2014
Drug Safety Alliance November 2010 - April 2012
Drug Safety Alliance December 2009 - April 2010
Dr Cynthia Gregg September 2004 - March 2010
Biolex September 2009 - December 2009
Fresenius Medical Care September 2007 - June 2009
Cary Academy August 1999 - August 2008
Skills
GCP, Drug Safety, Regulatory Affairs, Clinical Trials, Oncology, Pharmaceutical Industry, Clinical Research, Clinical Development, CRO, Case Management, Pharmacovigilance, Healthcare, Leadership
Education
Loyola University New Orleans 2007 — 2009
MSN, Master's of Health Care Systems Management, 4.0
University of North Carolina at Chapel Hill 2005 — 2006
Certificate, Clinical Research Associate
University of North Alabama
BSN, Nursing, 3.8
Donna Cook's Drug Safety Alliance Experience June 2007 - October 2007
Job Senior Regional Medical Liaison at ...and company
Industry Pharmaceuticals
Experience
Amgen, Inc. March 2009 - Present
Drug Safety Alliance June 2007 - October 2007
Amgen, Inc. May 2003 - April 2006
Immunex Corporation September 2000 - January 2003
drugstore.com March 1999 - August 2000
Texas Tech University School of Pharmacy August 1997 - March 1999
Skills
Pharmacovigilance, Drug Safety, Medicine, Oncology, Biotechnology, Clinical Trials, Pharmaceutical Industry, Clinical Development, Medical Affairs, Immunology, Drug Development, Rheumatology, Infectious Diseases, Lifesciences, Medical Writing, Clinical Research, Pharmaceutical Sales, Osteoporosis, Pharmacology, Life Sciences
Education
University of Washington 1994 — 1996
Doctor of Pharmacy, Pharmacy
University of North Carolina at Chapel Hill 1988 — 1993
Bachelor of Science, Pharmacy
Amgen, Inc. March 2009 - Present
Drug Safety Alliance June 2007 - October 2007
Amgen, Inc. May 2003 - April 2006
Immunex Corporation September 2000 - January 2003
drugstore.com March 1999 - August 2000
Texas Tech University School of Pharmacy August 1997 - March 1999
Skills
Pharmacovigilance, Drug Safety, Medicine, Oncology, Biotechnology, Clinical Trials, Pharmaceutical Industry, Clinical Development, Medical Affairs, Immunology, Drug Development, Rheumatology, Infectious Diseases, Lifesciences, Medical Writing, Clinical Research, Pharmaceutical Sales, Osteoporosis, Pharmacology, Life Sciences
Education
University of Washington 1994 — 1996
Doctor of Pharmacy, Pharmacy
University of North Carolina at Chapel Hill 1988 — 1993
Bachelor of Science, Pharmacy
Barbora Silva's Drug Safety Alliance Experience December 2010 - March 2011
Job Drug Safety Manager/ RN at Jazz Pharmaceuticals
Industry Biotechnology
Experience
Jazz Pharmaceuticals February 2015 - Present
Jazz Pharmaceuticals March 2014 - Present
Nektar Therapeutics October 2011 - March 2014
Drug Safety Alliance December 2010 - March 2011
Valeant Pharmaceuticals August 2010 - December 2010
Affymax, Inc., Palo Alto June 2009 - June 2010
Jazz Pharma, Inc, Palo Alto January 2009 - June 2009
Genentech, Inc January 2008 - December 2008
Global Regulatory Affairs & Safety January 2006 - January 2008
Johnson & Johnson October 2005 - October 2006
Skills
Fluent in Czech and..., Pharmacovigilance, Clinical Trials, Therapeutic Areas, Clinical Research, MedDRA, Infectious Diseases, Drug Safety, Protocol, Immunology, Drug Development, Regulatory Affairs, Clinical Monitoring, Computer System..., Sop, Oncology, Regulatory Submissions, Clinical Development, Pharmaceutical Industry, CRO, Biotechnology, GCP, Clinical Data Management, CTMS, SOP
Education
N. San Francisco State University 2002 — 2005
M.S; 2005, Nursing, Public Health Clinical Nurse Specialist
San Francisco State University 2002 — 2005
MSN, Nursing
San Jose State University 1997 — 1999
Bachelors, International Business
San Jose State University 1997 — 1999
B.S, Business Administration, International Business
Jazz Pharmaceuticals February 2015 - Present
Jazz Pharmaceuticals March 2014 - Present
Nektar Therapeutics October 2011 - March 2014
Drug Safety Alliance December 2010 - March 2011
Valeant Pharmaceuticals August 2010 - December 2010
Affymax, Inc., Palo Alto June 2009 - June 2010
Jazz Pharma, Inc, Palo Alto January 2009 - June 2009
Genentech, Inc January 2008 - December 2008
Global Regulatory Affairs & Safety January 2006 - January 2008
Johnson & Johnson October 2005 - October 2006
Skills
Fluent in Czech and..., Pharmacovigilance, Clinical Trials, Therapeutic Areas, Clinical Research, MedDRA, Infectious Diseases, Drug Safety, Protocol, Immunology, Drug Development, Regulatory Affairs, Clinical Monitoring, Computer System..., Sop, Oncology, Regulatory Submissions, Clinical Development, Pharmaceutical Industry, CRO, Biotechnology, GCP, Clinical Data Management, CTMS, SOP
Education
N. San Francisco State University 2002 — 2005
M.S; 2005, Nursing, Public Health Clinical Nurse Specialist
San Francisco State University 2002 — 2005
MSN, Nursing
San Jose State University 1997 — 1999
Bachelors, International Business
San Jose State University 1997 — 1999
B.S, Business Administration, International Business
Rosa Lee Smith's Drug Safety Alliance Experience November 2007 - November 2009
Job Director Global PV Project Management at UBC An Express Scripts Company
Industry Pharmaceuticals
Experience
UBC - An Express Scripts Company January 2015 - Present
HealthCare ConneXions, a division of Telerx 2012 - Present
Sentrx October 2012 - October 2013
Cell Therapeutics, Inc. - Seattle, WA June 2011 - October 2012
Quintiles 2009 - 2011
Drug Safety Alliance November 2007 - November 2009
PPD, Inc 2007 - 2007
Introgen Therapeutics, Inc. 2003 - 2006
Skills
Clinical Trials, Drug Safety, GCP, CRO, Pharmacovigilance, Oncology, Biotechnology, CTMS, Clinical Data Management, Clinical Development, Clinical Research, EDC, FDA, ICH-GCP, Medical Writing, Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, SOP
Education
Sam Rayburn HS 1984 — 1988
University of Houston
UBC - An Express Scripts Company January 2015 - Present
HealthCare ConneXions, a division of Telerx 2012 - Present
Sentrx October 2012 - October 2013
Cell Therapeutics, Inc. - Seattle, WA June 2011 - October 2012
Quintiles 2009 - 2011
Drug Safety Alliance November 2007 - November 2009
PPD, Inc 2007 - 2007
Introgen Therapeutics, Inc. 2003 - 2006
Skills
Clinical Trials, Drug Safety, GCP, CRO, Pharmacovigilance, Oncology, Biotechnology, CTMS, Clinical Data Management, Clinical Development, Clinical Research, EDC, FDA, ICH-GCP, Medical Writing, Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, SOP
Education
Sam Rayburn HS 1984 — 1988
University of Houston
Patti Rouse's Drug Safety Alliance Experience October 2012 - March 2013
Job PV Consultant at Foresight Group
Industry Pharmaceuticals
Experience
Foresight Group LLC September 2013 - May 2015
Drug Safety Alliance October 2012 - March 2013
King Pharmaceuticals (now Pfizer) July 2008 - October 2011
GlaxoSmithKline October 1986 - April 2008
Burroughs Wellcome September 1983 - October 1986
Skills
clinical research,..., Pharmaceutical Industry, Clinical Research, Quality Assurance, Pharmacovigilance, Clinical Development, GCP, Clinical Trials, Drug Development, FDA, Sop
Education
University of North Carolina at Chapel Hill
Bachelor of Science (B.S.), Pharmacy
Foresight Group LLC September 2013 - May 2015
Drug Safety Alliance October 2012 - March 2013
King Pharmaceuticals (now Pfizer) July 2008 - October 2011
GlaxoSmithKline October 1986 - April 2008
Burroughs Wellcome September 1983 - October 1986
Skills
clinical research,..., Pharmaceutical Industry, Clinical Research, Quality Assurance, Pharmacovigilance, Clinical Development, GCP, Clinical Trials, Drug Development, FDA, Sop
Education
University of North Carolina at Chapel Hill
Bachelor of Science (B.S.), Pharmacy
Angela Gautreau's Drug Safety Alliance Experience May 2007 - Present
Job Regulatory Associate II at Drug Safety Alliance
Industry Pharmaceuticals
Experience
Drug Safety Alliance May 2007 - Present
Education
North Carolina State University 1996 — 2000
Drug Safety Alliance May 2007 - Present
Education
North Carolina State University 1996 — 2000
Angela Gautreau's Drug Safety Alliance Experience February 2008 - April 2010
Job Clinical Safety Scientist, Global Safety and Pharmacovigilance at CTI Clinical Trials and Consulting
Industry Pharmaceuticals
Experience
CTI Clinical Trials and Consulting May 2013 - Present
Quintiles April 2010 - November 2011
Drug Safety Alliance February 2008 - April 2010
DSA May 2007 - February 2008
Salix November 2004 - May 2007
Cato Research 2002 - 2004
Skills
CRO, GCP, Clinical Trials, Regulatory Submissions, Regulatory Affairs, Pharmacovigilance, Pharmaceutical Industry, Clinical Development, CTMS, FDA, ICH-GCP, Oncology, EDC, Data Management, Sop
Education
North Carolina State University 1996 — 2000
Bachelor of Science, Zoology/Animal Biology
Beddingfield High School 1992 — 1996
CTI Clinical Trials and Consulting May 2013 - Present
Quintiles April 2010 - November 2011
Drug Safety Alliance February 2008 - April 2010
DSA May 2007 - February 2008
Salix November 2004 - May 2007
Cato Research 2002 - 2004
Skills
CRO, GCP, Clinical Trials, Regulatory Submissions, Regulatory Affairs, Pharmacovigilance, Pharmaceutical Industry, Clinical Development, CTMS, FDA, ICH-GCP, Oncology, EDC, Data Management, Sop
Education
North Carolina State University 1996 — 2000
Bachelor of Science, Zoology/Animal Biology
Beddingfield High School 1992 — 1996
Annette Williams's Drug Safety Alliance Experience October 2009 - April 2011
Job Vice President, Pharmacovigilance at Quintiles Inc
Industry Pharmaceuticals
Experience
Quintiles Inc January 2015 - Present
Quintiles Inc August 2014 - December 2014
Quintiles Inc January 2013 - July 2014
Quintiles Inc October 2011 - December 2012
Drug Safety Alliance October 2009 - April 2011
Drug Safety Alliance December 2006 - September 2009
TEAMM Pharmaceuticals April 2006 - October 2006
TEAMM Pharmaceuticals 2004 - 2006
GlaxoSmithKline 2001 - 2003
GlaxoSmithKline 1999 - 2001
Skills
Clinical Development, Pharmaceutical Sales, Pharmaceutical Industry, Clinical Trials, Regulatory Affairs, Oncology, Biotechnology, Data Management, Healthcare, Cross-functional Team..., GCP, Sop, Pharmacovigilance, CTMS, FDA, Lifesciences, Product Launch, EDC, Medical Writing, 21 CFR Part 11, ICH-GCP, Cardiology, Regulatory Submissions, Drug Development, Vaccines, Therapeutic Areas, Diabetes, Infectious Diseases, Biopharmaceuticals, CRO, Clinical Data Management, Clinical Monitoring, Drug Safety, Endocrinology, GMP, Managed Care, Medical Devices, Neurology, Pharmaceutics, Pharmacology, Validation, Account Management, Clinical Research
Education
Southern New Hampshire University 1992 — 1996
MBA
University of Rhode Island 1983 — 1988
BS, Pharmacy
Quintiles Inc January 2015 - Present
Quintiles Inc August 2014 - December 2014
Quintiles Inc January 2013 - July 2014
Quintiles Inc October 2011 - December 2012
Drug Safety Alliance October 2009 - April 2011
Drug Safety Alliance December 2006 - September 2009
TEAMM Pharmaceuticals April 2006 - October 2006
TEAMM Pharmaceuticals 2004 - 2006
GlaxoSmithKline 2001 - 2003
GlaxoSmithKline 1999 - 2001
Skills
Clinical Development, Pharmaceutical Sales, Pharmaceutical Industry, Clinical Trials, Regulatory Affairs, Oncology, Biotechnology, Data Management, Healthcare, Cross-functional Team..., GCP, Sop, Pharmacovigilance, CTMS, FDA, Lifesciences, Product Launch, EDC, Medical Writing, 21 CFR Part 11, ICH-GCP, Cardiology, Regulatory Submissions, Drug Development, Vaccines, Therapeutic Areas, Diabetes, Infectious Diseases, Biopharmaceuticals, CRO, Clinical Data Management, Clinical Monitoring, Drug Safety, Endocrinology, GMP, Managed Care, Medical Devices, Neurology, Pharmaceutics, Pharmacology, Validation, Account Management, Clinical Research
Education
Southern New Hampshire University 1992 — 1996
MBA
University of Rhode Island 1983 — 1988
BS, Pharmacy
Sharon Donatucci's Drug Safety Alliance Experience July 2011 - September 2013
Job Vice President, Pharmacovigilance Sciences at Ashfield Pharmacovigilance
Industry Pharmaceuticals
Experience
Ashfield Pharmacovigilance February 2015 - Present
Drug Safety Alliance I Ashfield Pharmacovigilance September 2013 - February 2015
Drug Safety Alliance July 2011 - September 2013
Drug Safety Alliance November 2009 - July 2011
Drug Safety Alliance October 2004 - November 2009
Drug Safety Alliance October 2000 - October 2004
Skills
Clinical Trials, Drug Safety, Pharmacovigilance, Clinical Development, Quality Assurance, Sop, Training, Quality Management, GCP, FDA, Process Improvement, Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, EDC, 21 CFR Part 11
Education
San Jose State University 1983 — 1985
BSEE, Electrical Engineering
Gwynedd Mercy University 1974 — 1976
AS, Cardio-pulmonary Technology
Gwynedd Mercy Academy 1968 — 1972
Ashfield Pharmacovigilance February 2015 - Present
Drug Safety Alliance I Ashfield Pharmacovigilance September 2013 - February 2015
Drug Safety Alliance July 2011 - September 2013
Drug Safety Alliance November 2009 - July 2011
Drug Safety Alliance October 2004 - November 2009
Drug Safety Alliance October 2000 - October 2004
Skills
Clinical Trials, Drug Safety, Pharmacovigilance, Clinical Development, Quality Assurance, Sop, Training, Quality Management, GCP, FDA, Process Improvement, Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, EDC, 21 CFR Part 11
Education
San Jose State University 1983 — 1985
BSEE, Electrical Engineering
Gwynedd Mercy University 1974 — 1976
AS, Cardio-pulmonary Technology
Gwynedd Mercy Academy 1968 — 1972
Pat Endsley's Drug Safety Alliance Experience December 2009 - June 2010
Job Clinical Trial Coordinator III at Duke Clinical Research Institute
Industry Pharmaceuticals
Experience
Duke Clinical Research Institute February 2014 - Present
Duke Clinical Research Institute June 2011 - February 2014
Quintiles June 2010 - May 2011
Drug Safety Alliance December 2009 - June 2010
PPD June 2007 - December 2009
BCBSNC July 2006 - June 2007
Mid-America Cardiology April 1992 - April 1998
Skills
CRO, Drug Safety, Clinical Trials, Clinical Research, GCP, Cardiovascular Disease, EDC, Therapeutic Areas, ICH-GCP, Clinical Data Management, Diabetes, Oncology, Team Leadership, SOP, Clinical Monitoring, Clinical Development
Education
Park University
BS, Social Psychology
University of Missouri-Kansas City
MA, Special Education
Duke Clinical Research Institute February 2014 - Present
Duke Clinical Research Institute June 2011 - February 2014
Quintiles June 2010 - May 2011
Drug Safety Alliance December 2009 - June 2010
PPD June 2007 - December 2009
BCBSNC July 2006 - June 2007
Mid-America Cardiology April 1992 - April 1998
Skills
CRO, Drug Safety, Clinical Trials, Clinical Research, GCP, Cardiovascular Disease, EDC, Therapeutic Areas, ICH-GCP, Clinical Data Management, Diabetes, Oncology, Team Leadership, SOP, Clinical Monitoring, Clinical Development
Education
Park University
BS, Social Psychology
University of Missouri-Kansas City
MA, Special Education
Desnee Wynn Herring, MBA, MHA's Drug Safety Alliance Experience October 2012 - May 2014
Job Drug Safety Coordinator at Theorem Clinical Research
Industry Pharmaceuticals
Experience
Theorem Clinical Research January 2015 - Present
Hospira Inc. September 2014 - January 2015
Drug Safety Alliance / Ashfield Pharmacovigilance May 2014 - August 2014
Drug Safety Alliance October 2012 - May 2014
Catalent Pharma Solutions December 2009 - May 2012
GlaxoSmithKline July 2002 - June 2008
Wake Forest Baptist Health August 1995 - July 2002
Skills
GCP, Pharmaceutical Industry, Clinical Trials, Validation, CRO, GLP, Clinical Research, FDA, SOP, In Vitro, Molecular Biology, Assay Development, ELISA, Pharmacovigilance, Drug Development, Drug Discovery, Purification, Project Management, Project Coordination, Drug Safety, Regulatory Submissions, FDA GMP, Training & Development, Case Studies, Biotechnology, Clinical Development
Education
Project Management Institute (PMI) 2014 — 2015
PMP / SCRUM, CSM, Project Management
Pfeiffer University
Master of Business Administration (M.B.A.)
Pfeiffer University
Master of Health Administration (M.H.A.)
University of North Carolina at Chapel Hill
Bachelor's Degree, Biology
University of North Carolina at Greensboro
Public Health
Theorem Clinical Research January 2015 - Present
Hospira Inc. September 2014 - January 2015
Drug Safety Alliance / Ashfield Pharmacovigilance May 2014 - August 2014
Drug Safety Alliance October 2012 - May 2014
Catalent Pharma Solutions December 2009 - May 2012
GlaxoSmithKline July 2002 - June 2008
Wake Forest Baptist Health August 1995 - July 2002
Skills
GCP, Pharmaceutical Industry, Clinical Trials, Validation, CRO, GLP, Clinical Research, FDA, SOP, In Vitro, Molecular Biology, Assay Development, ELISA, Pharmacovigilance, Drug Development, Drug Discovery, Purification, Project Management, Project Coordination, Drug Safety, Regulatory Submissions, FDA GMP, Training & Development, Case Studies, Biotechnology, Clinical Development
Education
Project Management Institute (PMI) 2014 — 2015
PMP / SCRUM, CSM, Project Management
Pfeiffer University
Master of Business Administration (M.B.A.)
Pfeiffer University
Master of Health Administration (M.H.A.)
University of North Carolina at Chapel Hill
Bachelor's Degree, Biology
University of North Carolina at Greensboro
Public Health
Jason Putney's Drug Safety Alliance Experience 2006 - 2007
Job Manager of Information Technology at USfalcon
Industry Defense & Space
Experience
USfalcon December 2007 - June 2010
Drug Safety Alliance 2006 - 2007
W.A. Wilde Company June 2004 - August 2006
State Street Global Advisors October 1999 - October 2003
Mintz Levin September 1991 - October 1998
Education
Northeastern University 2004 — 2006
BA, Leadership & Management
Massachusetts Communications College 1995 — 1997
AS, Audio Engineering
USfalcon December 2007 - June 2010
Drug Safety Alliance 2006 - 2007
W.A. Wilde Company June 2004 - August 2006
State Street Global Advisors October 1999 - October 2003
Mintz Levin September 1991 - October 1998
Education
Northeastern University 2004 — 2006
BA, Leadership & Management
Massachusetts Communications College 1995 — 1997
AS, Audio Engineering
Felicia Terry-Boyles, PHR's Drug Safety Alliance Experience October 2013 - Present
Job HR Manager at Drug Safety Alliance, Inc.
Industry Human Resources
Experience
Drug Safety Alliance October 2013 - Present
GFI Software July 2012 - June 2013
Carolina Sunrock LLC 2007 - 2011
Skills
Career Development, Benefits Administration, HRIS, Employee Relations, Performance Management, Onboarding, Employee Benefits, Compliance, Talent Management, Orientation, Compensation, Abra, Payroll, Talent Acquisition, Recruiting, Deferred Compensation, New Hire Orientations, ADP Payroll, Personnel Management
Education
North Carolina State University - College of Management
B.S., Business Management
Drug Safety Alliance October 2013 - Present
GFI Software July 2012 - June 2013
Carolina Sunrock LLC 2007 - 2011
Skills
Career Development, Benefits Administration, HRIS, Employee Relations, Performance Management, Onboarding, Employee Benefits, Compliance, Talent Management, Orientation, Compensation, Abra, Payroll, Talent Acquisition, Recruiting, Deferred Compensation, New Hire Orientations, ADP Payroll, Personnel Management
Education
North Carolina State University - College of Management
B.S., Business Management
Susan Bartone's Drug Safety Alliance Experience June 2004 - October 2007
Job Medical Product Safety Specialist at RTI
Industry Pharmaceuticals
Experience
RTI-Health Solutions October 2007 - Present
RTI-Health Solutions October 2007 - Present
RTI Health Solutions October 2007 - Present
RTI-Health Solutions October 2007 - Present
RTI-Health Solutions October 2007 - Present
RTI-Health Solutions October 2007 - Present
BIOPHARMACEUTICAL QUALIFICATIONS June 2003 - Present
Drug Safety Alliance June 2004 - October 2007
Drug Safety Alliance 2004 - 2007
PAREXEL International Corporation January 2003 - February 2004
Education
State of North Carolina Board of Nursing
Master's, Research
University of North Carolina at Chapel Hill
Master of Science; School, Nursing; Nursing; Information and Library Science
Nazareth College
Bachelor of Science, Nursing
RTI-Health Solutions October 2007 - Present
RTI-Health Solutions October 2007 - Present
RTI Health Solutions October 2007 - Present
RTI-Health Solutions October 2007 - Present
RTI-Health Solutions October 2007 - Present
RTI-Health Solutions October 2007 - Present
BIOPHARMACEUTICAL QUALIFICATIONS June 2003 - Present
Drug Safety Alliance June 2004 - October 2007
Drug Safety Alliance 2004 - 2007
PAREXEL International Corporation January 2003 - February 2004
Education
State of North Carolina Board of Nursing
Master's, Research
University of North Carolina at Chapel Hill
Master of Science; School, Nursing; Nursing; Information and Library Science
Nazareth College
Bachelor of Science, Nursing
Mickey Holsey's Drug Safety Alliance Experience 2007 - 2013
Job Senior Consultant at Foresight Group International, AG
Industry Pharmaceuticals
Experience
Foresight Group International, AG 2013 - Present
Drug Safety Alliance 2007 - 2013
Stanton Software 2006 - 2007
New Hope Christian School 2003 - 2006
Lees-McRae College 2001 - 2003
Skills
Databases, Software Development, 21 CFR Part 11, ETL, Clinical Trials, Database Design, SQL, Microsoft SQL Server, Object Oriented Design, C++/C#, ASP.NET, Oracle 11g, Toad, Oracle Argus 7, Oracle Argus Insight 7, Empirica Trace, Cognos, Oracle AERS, OAM 10g, Pharmacovigilance, Computer System..., IT Project & Program..., Mathematical Analysis, Mathematical Programming, SOP development, Oracle, CRO, Requirements Analysis, GCP
Education
Appalachian State University
M.S., Computer Science
University of Illinois at Urbana-Champaign
Ph.D., Mathematics
Foresight Group International, AG 2013 - Present
Drug Safety Alliance 2007 - 2013
Stanton Software 2006 - 2007
New Hope Christian School 2003 - 2006
Lees-McRae College 2001 - 2003
Skills
Databases, Software Development, 21 CFR Part 11, ETL, Clinical Trials, Database Design, SQL, Microsoft SQL Server, Object Oriented Design, C++/C#, ASP.NET, Oracle 11g, Toad, Oracle Argus 7, Oracle Argus Insight 7, Empirica Trace, Cognos, Oracle AERS, OAM 10g, Pharmacovigilance, Computer System..., IT Project & Program..., Mathematical Analysis, Mathematical Programming, SOP development, Oracle, CRO, Requirements Analysis, GCP
Education
Appalachian State University
M.S., Computer Science
University of Illinois at Urbana-Champaign
Ph.D., Mathematics
Jane Parker's Drug Safety Alliance Experience December 2012 - August 2013
Job Clinical Data Management Theorem Clinical Research
Industry Pharmaceuticals
Experience
Theorem Clinical Research January 2015 - Present
Chiltern April 2014 - December 2014
LabCorp Clinical Trials September 2013 - February 2014
Drug Safety Alliance December 2012 - August 2013
INC Research June 2011 - December 2012
PPD October 2008 - February 2011
PPD June 2006 - October 2008
UNC Health Care September 2005 - June 2006
UNC Health Care December 2003 - August 2005
UNC Health Care November 2002 - December 2003
Skills
Clinical Trials, CRO, Clinical Research, FDA, Quality Assurance, Infectious Diseases, Protocol, Data Management, Oracle Clinical, GCP, EDC, Drug Safety, Oncology, Validation, Clinical Data Management
Education
University of North Carolina at Chapel Hill 1980 — 1982
BS, Medical Technology
Peace College 1978 — 1980
AA, Liberal Arts and Sciences/Liberal Studies
Theorem Clinical Research January 2015 - Present
Chiltern April 2014 - December 2014
LabCorp Clinical Trials September 2013 - February 2014
Drug Safety Alliance December 2012 - August 2013
INC Research June 2011 - December 2012
PPD October 2008 - February 2011
PPD June 2006 - October 2008
UNC Health Care September 2005 - June 2006
UNC Health Care December 2003 - August 2005
UNC Health Care November 2002 - December 2003
Skills
Clinical Trials, CRO, Clinical Research, FDA, Quality Assurance, Infectious Diseases, Protocol, Data Management, Oracle Clinical, GCP, EDC, Drug Safety, Oncology, Validation, Clinical Data Management
Education
University of North Carolina at Chapel Hill 1980 — 1982
BS, Medical Technology
Peace College 1978 — 1980
AA, Liberal Arts and Sciences/Liberal Studies
Renee Helms, DVM's Drug Safety Alliance Experience May 2011 - April 2012
Job Director, Pharmacovigilance Operations
Industry Pharmaceuticals
Experience
Drug Safety Alliance Ashfield Pharmacovigilance January 2015 - Present
Crossroads Veterinary Hospital February 2014 - Present
Drug Safety Alliance, Inc. June 2014 - January 2015
Animal Emergency Clinic of Cary January 2004 - July 2014
Drug Safety Alliance, Inc. April 2012 - June 2014
Drug Safety Alliance May 2011 - April 2012
PPD July 2005 - January 2011
PPD 2005 - 2011
Zebulon Animal Hosptial 2004 - 2005
Skills
Pharmacovigilance, Customer Service, Pharmaceutical Industry, Clinical Research, GCP, Clinical Trials, Veterinary Medicine, Veterinary, FDA, Regulatory Affairs, Clinical Development, Vaccines, Oncology, Infectious Diseases
Education
North Carolina State University 1997 — 2001
DVM, Veterinary Medicine
University of North Carolina at Wilmington 1987 — 1990
BS, Business Management
Drug Safety Alliance Ashfield Pharmacovigilance January 2015 - Present
Crossroads Veterinary Hospital February 2014 - Present
Drug Safety Alliance, Inc. June 2014 - January 2015
Animal Emergency Clinic of Cary January 2004 - July 2014
Drug Safety Alliance, Inc. April 2012 - June 2014
Drug Safety Alliance May 2011 - April 2012
PPD July 2005 - January 2011
PPD 2005 - 2011
Zebulon Animal Hosptial 2004 - 2005
Skills
Pharmacovigilance, Customer Service, Pharmaceutical Industry, Clinical Research, GCP, Clinical Trials, Veterinary Medicine, Veterinary, FDA, Regulatory Affairs, Clinical Development, Vaccines, Oncology, Infectious Diseases
Education
North Carolina State University 1997 — 2001
DVM, Veterinary Medicine
University of North Carolina at Wilmington 1987 — 1990
BS, Business Management
Ruth Goslin's Drug Safety Alliance Experience May 2001 - June 2012
Job Contract Drug Safety Associate at Drug Safety Alliance, Inc.
Industry Pharmaceuticals
Experience
Drug Safety Alliance, Inc. October 2013 - August 2014
Drug Safety Alliance May 2001 - June 2012
Skills
MedDRA, Drug Safety, Pharmacovigilance, CRO, Adverse Events, Narrative, Therapeutic Areas, Medical Writing, GCP, CTMS, Oncology, ICH-GCP, Regulatory Affairs, Pharmaceutical Industry, SOP, FDA
Education
University of Chicago 1973 — 1974
MAT, English
Berea College 1969 — 1974
BA, English
Drug Safety Alliance, Inc. October 2013 - August 2014
Drug Safety Alliance May 2001 - June 2012
Skills
MedDRA, Drug Safety, Pharmacovigilance, CRO, Adverse Events, Narrative, Therapeutic Areas, Medical Writing, GCP, CTMS, Oncology, ICH-GCP, Regulatory Affairs, Pharmaceutical Industry, SOP, FDA
Education
University of Chicago 1973 — 1974
MAT, English
Berea College 1969 — 1974
BA, English
Delores Rowe's Drug Safety Alliance Experience November 2005 - May 2011
Job Human Resources/Office Manager at Drug Safety Alliance
Industry Pharmaceuticals
Experience
Drug Safety Alliance November 2005 - May 2011
Skills
Human Resources, Recruiting, Payroll, Business Development, Process Improvement, Training, Interviews, Talent Management, Customer Satisfaction, Management, Microsoft Office
Education
Old Dominion University
BS, Business Administration
Drug Safety Alliance November 2005 - May 2011
Skills
Human Resources, Recruiting, Payroll, Business Development, Process Improvement, Training, Interviews, Talent Management, Customer Satisfaction, Management, Microsoft Office
Education
Old Dominion University
BS, Business Administration
Susan Bartone's Drug Safety Alliance Experience 2004 - 2007
Job Safety Specialist II at INC Research
Industry Pharmaceuticals
Experience
INC Research November 2011 - Present
RTI-HS October 2007 - October 2011
Drug Safety Alliance 2004 - 2007
WakeMed 1996 - 2001
Education
University of North Carolina at Chapel Hill 1998 — 2002
Masters in Nursing, Health Care Systems
Nazareth College 1983 — 1987
Bachelor of Science in Nursing, Nursing
INC Research November 2011 - Present
RTI-HS October 2007 - October 2011
Drug Safety Alliance 2004 - 2007
WakeMed 1996 - 2001
Education
University of North Carolina at Chapel Hill 1998 — 2002
Masters in Nursing, Health Care Systems
Nazareth College 1983 — 1987
Bachelor of Science in Nursing, Nursing
Susan Birkenstock's Drug Safety Alliance Experience August 2004 - May 2006
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Telerx (formerly Sentrx) July 2012 - Present
Lewis & Roberts February 2012 - June 2012
United Therapeutics (contractor Trio Clinical Research) October 2010 - May 2011
King Pharmaceuticals, Cary, NC (contractor Trio Clinical Research) September 2008 - September 2010
GlaxoSmithKline (contractor Trio Clinical Research) October 2006 - April 2008
King Pharmaceuticals (contractor Trio Clinical Research) August 2006 - March 2007
Drug Safety Alliance August 2004 - May 2006
GlaxoSmithKline (contractor Ranstad Research) November 1998 - February 2004
Glaxo Wellcome, Inc. November 1994 - November 1998
Glaxo Inc. November 1992 - November 1993
Skills
Pharmacovigilance, Clinical Research, Clinical Trials, Regulatory Submissions, Pharmaceutical Industry, Team Building, Healthcare, FDA
Education
University of North Carolina at Chapel Hill
BSN, Nursing
Telerx (formerly Sentrx) July 2012 - Present
Lewis & Roberts February 2012 - June 2012
United Therapeutics (contractor Trio Clinical Research) October 2010 - May 2011
King Pharmaceuticals, Cary, NC (contractor Trio Clinical Research) September 2008 - September 2010
GlaxoSmithKline (contractor Trio Clinical Research) October 2006 - April 2008
King Pharmaceuticals (contractor Trio Clinical Research) August 2006 - March 2007
Drug Safety Alliance August 2004 - May 2006
GlaxoSmithKline (contractor Ranstad Research) November 1998 - February 2004
Glaxo Wellcome, Inc. November 1994 - November 1998
Glaxo Inc. November 1992 - November 1993
Skills
Pharmacovigilance, Clinical Research, Clinical Trials, Regulatory Submissions, Pharmaceutical Industry, Team Building, Healthcare, FDA
Education
University of North Carolina at Chapel Hill
BSN, Nursing
Linda Progelhof's Drug Safety Alliance Experience January 2007 - June 2010
Job Senior Clinical Safety Scientist at CTI Consulting
Industry Pharmaceuticals
Experience
CTI Clinical Trials and Consulting October 2011 - Present
Novella Clinical, Inc. June 2010 - September 2011
Drug Safety Alliance January 2007 - June 2010
PPD October 2004 - December 2006
PPD May 2003 - October 2004
PPD November 1999 - April 2003
SUPERVALU September 1995 - August 1999
Rite Aid August 1993 - June 1995
Rite Aid July 1989 - August 1993
Education
University of South Carolina-Columbia
BS, Pharmacy
CTI Clinical Trials and Consulting October 2011 - Present
Novella Clinical, Inc. June 2010 - September 2011
Drug Safety Alliance January 2007 - June 2010
PPD October 2004 - December 2006
PPD May 2003 - October 2004
PPD November 1999 - April 2003
SUPERVALU September 1995 - August 1999
Rite Aid August 1993 - June 1995
Rite Aid July 1989 - August 1993
Education
University of South Carolina-Columbia
BS, Pharmacy
Teneisha Adams's Drug Safety Alliance Experience January 2010 - March 2011
Job Compliance Analyst at GlaxoSmithKline
Industry Pharmaceuticals
Experience
GlaxoSmithKline March 2011 - Present
Drug Safety Alliance January 2010 - March 2011
Skills
Validation, Pharmaceutical Industry
Education
Fayetteville State University
GlaxoSmithKline March 2011 - Present
Drug Safety Alliance January 2010 - March 2011
Skills
Validation, Pharmaceutical Industry
Education
Fayetteville State University
Carolyn Davenport's Drug Safety Alliance Experience 2000 - 2004
Job Medical Data Reviewer at UCB BioSciences, Inc
Industry Pharmaceuticals
Experience
UCB BioSciences, Inc January 2011 - Present
UCB BioSciences, Inc July 2009 - December 2010
UNC CH School of Nursing 2004 - 2009
Drug Safety Alliance 2000 - 2004
Glaxo Wellcome (now GlaxoSmithKline) 1986 - 1999
Skills
Clinical Research, Clinical Trials, Clinical Development, GCP, Pharmaceutical Industry, Medicine, ICH-GCP
Education
East Carolina University 1981 — 1984
BS, Nursing
UNC Chapel Hill 1976 — 1978
BA, Botany
Denison University 1973 — 1975
UCB BioSciences, Inc January 2011 - Present
UCB BioSciences, Inc July 2009 - December 2010
UNC CH School of Nursing 2004 - 2009
Drug Safety Alliance 2000 - 2004
Glaxo Wellcome (now GlaxoSmithKline) 1986 - 1999
Skills
Clinical Research, Clinical Trials, Clinical Development, GCP, Pharmaceutical Industry, Medicine, ICH-GCP
Education
East Carolina University 1981 — 1984
BS, Nursing
UNC Chapel Hill 1976 — 1978
BA, Botany
Denison University 1973 — 1975
Sheva Doyle, MS's Drug Safety Alliance Experience 2008 - 2009
Job Experienced Clinical Research Professional
Industry Biotechnology
Experience
SRA International 2009 - 2011
Drug Safety Alliance 2008 - 2009
PharmaNet/i3 2007 - 2007
ClinForce 2007 - 2007
PPD 2006 - 2007
Quintiles 2006 - 2006
Skills
Pharmaceutical Industry, Drug Safety, Clinical Research, Medidata, Oracle Database, Oracle RDC, Argus Safety, ARISg, AERS, VAERS, Vaccine Research, MedDRA, Medical Terminology, Oncology Clinical..., Pharmacovigilance, Clinical Data Management, Medical Coding, FDA, ICH-GCP, Cardiology, Oncology, CTMS, GCP, EDC
Education
Walden University 2009 — 2011
Master of Science, Clinical Research Administration
Elizabeth City State University 1995 — 1999
Bachelors, Biology/Chemistry
SRA International 2009 - 2011
Drug Safety Alliance 2008 - 2009
PharmaNet/i3 2007 - 2007
ClinForce 2007 - 2007
PPD 2006 - 2007
Quintiles 2006 - 2006
Skills
Pharmaceutical Industry, Drug Safety, Clinical Research, Medidata, Oracle Database, Oracle RDC, Argus Safety, ARISg, AERS, VAERS, Vaccine Research, MedDRA, Medical Terminology, Oncology Clinical..., Pharmacovigilance, Clinical Data Management, Medical Coding, FDA, ICH-GCP, Cardiology, Oncology, CTMS, GCP, EDC
Education
Walden University 2009 — 2011
Master of Science, Clinical Research Administration
Elizabeth City State University 1995 — 1999
Bachelors, Biology/Chemistry
John Reynolds, MD's Drug Safety Alliance Experience 2002 - 2005
Job Medical Director at Pfizer
Industry Pharmaceuticals
Experience
Pfizer 2013 - Present
Kraken Consulting 2010 - 2013
Talecris Biotherapeutics, Inc. 2007 - 2010
Orbis Clinical 2006 - 2009
Abraxis BioScience 2005 - 2007
Drug Safety Alliance 2002 - 2005
PPD 2001 - 2002
Skills
Drug Safety, Pharmacovigilance, Drug Development, Regulatory Affairs, Medicine, Signal Detection, Pharmacovigilance..., Global Regulatory..., Medical Affairs, Regulatory Inspections, Oncology, Clinical Trials, FDA, GCP, Life Sciences
Education
University of North Carolina at Chapel Hill
Doctor of Medicine (MD)
University of North Carolina at Chapel Hill
Bachelor of Science (BS), Chemistry, Psychology
Pfizer 2013 - Present
Kraken Consulting 2010 - 2013
Talecris Biotherapeutics, Inc. 2007 - 2010
Orbis Clinical 2006 - 2009
Abraxis BioScience 2005 - 2007
Drug Safety Alliance 2002 - 2005
PPD 2001 - 2002
Skills
Drug Safety, Pharmacovigilance, Drug Development, Regulatory Affairs, Medicine, Signal Detection, Pharmacovigilance..., Global Regulatory..., Medical Affairs, Regulatory Inspections, Oncology, Clinical Trials, FDA, GCP, Life Sciences
Education
University of North Carolina at Chapel Hill
Doctor of Medicine (MD)
University of North Carolina at Chapel Hill
Bachelor of Science (BS), Chemistry, Psychology