Senior Medical Director - Patient Safety

Role: Lead pharmacovigilance for late-stage oncology products, overseeing safety strategy throughout the product lifecycle. Responsibilities: manage safety surveillance, develop pharmacovigilance strategies for regulatory documents, interpret aggregate safety data, lead safety components of NDA/sNDA submissions, and implement risk management plans. Collaborate closely with development, regulatory, medical affairs, and cross-functional teams to guide dose, regimen, safety monitoring, and regulatory compliance. Requirements: MD/DO with 2+ years in internal medicine residency and patient management; 2-5 years in pharmacovigilance or clinical development within pharma; oncology safety experience essential; prior support for IND/BLA submissions preferred. HighValue: oncology, late-stage development, pharmacovigilance, regulatory submissions, safety signal detection, risk management, cross-functional collaboration, potentially supporting biologics or combination products. WorkSetup: not specified; travel requirements not indicated.