Patient Safety Associate Medical Director
Core
Provides medical safety expertise, state-of-the-art pharmacovigilance, and safety risk management for assigned products (marketed or in development) to optimize patient safety and ensure regulatory compliance globally.
Role type
Senior IC Medical Director (Pharmacovigilance)
Builds
Safety assessment activities, periodic reports (DSUR, PSUR, PADER), and clinical study safety data analysis for Vertex products.
Domain
Biotechnology / Pharmacovigilance / Clinical Safety
Required skills
Pharmacovigilance, clinical safety, safety signal identification, aggregate safety analysis, regulatory agency interactions, medical evaluation of safety data, protocol development, statistical analysis, DSUR/PSUR/PADER preparation
Preferred skills
Pharmacoepidemiology, data management systems, toxicology review, non-clinical study evaluation, partner/affiliate agreement support
Technologies
Clinical trial protocols, statistical analysis plans, aggregate safety reports, periodic safety update reports
Responsibilities
Lead safety and risk management processes including chairing Disease-area Safety and Product Safety Teams; identify, prioritize, and analyze clinical safety signals; perform ongoing review of emerging safety data from various sources; conduct medical evaluation of safety-related information from Toxicology, Non-Clinical studies, and Product Quality complaints; participate in protocol development and analysis of safety data from clinical trials; contribute to preparation and review of periodic reports (DSUR, PSUR, PADER); provide guidance to staff on adverse experience report processing.
Seniority
Senior, hands-on IC with strategic focus