Senior Manager, Global Patient Safety - General Medicine

Role: Senior Manager, Global Patient Safety responsible for safety strategy and signal management in clinical development and post-marketing. Responsibilities include signal detection, evaluation, safety documentation (DSUR, PSUR, RMP), and risk management activities, as well as representing GPS on cross-functional teams. Requires participation in process improvements and safety oversight activities. Qualifications: Master's, PhD, or PharmD with 7+ years in risk management within pharma/biotech or health authorities; strong knowledge of FDA, EU, ICH pharmacovigilance guidelines; experience with safety databases; effective communication skills. High-Value: Focus on safety in clinical and post-marketing phases, safety reporting, signal evaluation, cross-functional collaboration, risk management, and compliance. Work setup: On-site 4 days/week in Tarrytown, NY or Warren, NJ.