CSRM Physician - Senior Principal Scientist, Drug Safety

Role: CSRM Physician leading pharmacovigilance and clinical risk management for assigned products, including investigational and marketed drugs. Responsibilities: chair Risk Management Safety Team, develop and maintain pharmacovigilance plans, evaluate safety data from clinical trials, literature, and post-market sources; contribute to safety-related regulatory documents (e.g., RMP, PSURs); oversee safety surveillance activities, and collaborate with cross-functional teams (clinical development, epidemiology, regulatory, manufacturing). Requirements: MD, DO or equivalent; 3+ years clinical post-training experience; prior drug development, safety, pharmacovigilance, or risk management experience; strong communication and analytical skills; expertise in safety data evaluation, GxP, FDA regulations, and MedDRA. Preferred: Board certification. HighValue: focus on safety/risks in drug development; involvement in regulatory submissions and safety signal review; cross-functional collaboration in pharmacovigilance; hybrid work setup, with no travel specified.