Director, Drug Safety & Pharmacovigilance Operations

Role: Senior operational leader overseeing global pharmacovigilance (PV) activities across clinical and postmarketing products, focusing on safety data collection, case processing, and compliance. Responsibilities: manage end-to-end ICSR workflows, safety data exchange, vendor oversight, and inspection readiness; develop safety management strategies, ensure regulatory compliance, lead signal detection and benefit-risk assessments; build cross-functional partnerships with Clinical, Regulatory, Quality, Medical, and external vendors; and govern safety systems and technology. Requirements: Bachelor’s in healthcare or life sciences; 10+ years in PV/Drug Safety with experience managing complex operations and third-party vendors; strong knowledge of global PV regulations, safety databases (e.g., Argus, ARISg), MedDRA, and electronic safety reporting. Preferred: leadership in global PV programs, expertise in regulatory submissions, PV system validation, and inspection management; ability to influence at senior levels and manage cross-functional initiatives. High-Value: expertise in ICH, FDA, EMA, GVP standards; experience with safety systems, signal detection, and risk management; vendor management and automation initiatives. Work setup: onsite at South San Francisco headquarters with regular schedule, some travel anticipated.