Senior Medical Director - Patient Safety

Role: Lead pharmacovigilance for late-stage oncology products, overseeing safety surveillance, signal detection, risk assessment, and regulatory submissions throughout product lifecycle. Responsibilities: develop and implement safety strategies, interpret clinical and non-clinical safety data, author and review PV documents, manage risk mitigation plans, and support regulatory activities including NDA/sNDA submissions and labeling updates. Requirements: MD/DO with 2+ years in internal medicine and patient management; 2-5 years pharmacovigilance or clinical development experience, particularly in oncology; prior experience supporting IND/BLA filings; strong analytical skills for clinical and epidemiological data; ability to lead cross-functional teams and communicate safety insights effectively. Preferred qualifications: PhD or Clinical Pharmacology fellowship is a plus. High-value: oncology (late-stage, likely clinical trial focus), pharmacovigilance, safety signal detection, regulatory submissions, risk management, cross-disciplinary collaboration, supporting Oncology therapeutic area. Work setup details are not specified.