Director, Pharmacovigilance / Product Safety

Role: Director of Pharmacovigilance / Product Safety responsible for safety surveillance, risk management, and benefit-risk assessments of assigned biopharmaceutical products, including both investigational and marketed assets. Responsibilities include medical review of adverse events, safety signal detection, leading safety review teams, developing risk management systems, and ensuring compliance with international regulations (e.g., ICH, GVP). The role involves providing medical safety input into clinical development documents, developing and managing REMS and RMPs, and collaborating cross-functionally with Clinical Development, Regulatory, Quality, and Commercial teams. Qualifications: MD or DO with 2+ years clinical patient care, 5+ years in pharmaceutical drug safety/pharmacovigilance covering investigational and marketed products, and 3+ years in medical case review, safety surveillance, and risk management. Knowledge of PV regulations, safety databases, and regulatory reporting required. Preferred: experience presenting safety topics at regulatory meetings and familiarity with safety databases. High-value biopharma specifics include focus on serious diseases, post-marketing safety, and managing benefit-risk profiles. This is a fully remote role with occasional US travel (up to 20%).