Kevin Flanagan
Retired
- Role
- Director, Pharmacovogilance Compliance at Novavax
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Kevin Flanagan
Pharmaceutical professional experienced in drug safety data management, regulatory compliance, quality assurance, PSMF maintenance, SOPs, Electronic Discovery, Pharmacovigilance Agreements (SDEAs), Medical Information, Marketing Communications and UAT (User Acceptance Testing)/ smoke testing. Directed, trained, motivated and assessed outstanding and productive staff throughout career.
Experience
Director, Pharmacovogilance Compliance
Feb 2021 — Present · Gaithersburg, MD, US
Education
Caldwell University
BA, Psychology
1998
Rutgers University
MLS, Information Structures and Systems
1999 — 2000
Skills
- Program Management
- Management
- Clinical Research
- Medical Writing
- Regulatory Requirements
- Compliance
- Biotechnology
- Cardiology
- Oncology
- Clinical Data Management
- Oracle Clinical
- Good Clinical Practice (Gcp)
- Strategy
- Ich-Gcp
- Standard Operating Procedure (Sop)
- Regulatory Submissions
- Computer System Validation
- Gcp
- Biopharmaceuticals
- Infectious Diseases
- Risk Assessment
- Neurology
- Pharmacovigilance
- Data Management
- Governance
- Pharmaceutical Industry
- Sop
- Fda
- Drug Safety
- Human Resources
- 21 Cfr Part 11
- Therapeutic Areas
- Ctms
- Market Access
- CRO
- E-Discovery Consulting
- Clinical Development
- Clinical Trials
- Life Sciences
- Change Management
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