Clinical Safety and Risk Management Principal Scientist
Core
Lead pharmacovigilance and clinical risk management for marketed pharmaceutical products, overseeing safety surveillance, risk management plans, and regulatory safety documentation.
Role type
Principal Scientist, Clinical Safety and Risk Management (Pharmacovigilance)
Builds
Risk Management Plans (RMP), Periodic Safety Update Reports (PSUR), safety summaries, and regulatory safety sections for product labels.
Domain
Pharmaceutical industry, Drug Safety, Pharmacovigilance
Required skills
Medical Judgment, Causality Assessment, Aggregate Safety Data Analysis, Safety Document Authoring, Risk Minimization Strategy, Regulatory Compliance, MedDRA Knowledge, Safety Database Management, Epidemiology, Clinical Trial Oversight
Preferred skills
Medical Specialty, Program Management, Stakeholder Influence
Technologies
Safety Databases, MedDRA
Responsibilities
Chair the Risk Management Safety Team (RMST) for assigned products; evaluate safety data from clinical trials, literature, and post-approval use; develop and maintain Risk Management Plans and pharmacovigilance strategies; supervise safety data analysis and regulatory document authoring; review and approve product labelling files; participate in standards and process development.
Seniority
Senior, hands-on IC with leadership responsibilities
