Director, Pharmacovigilance Operations

Role: Lead global pharmacovigilance operations for Neurogene's clinical and future commercial gene therapy products, ensuring compliance and operational efficiency. Responsibilities: develop PV strategy, oversee vendor management, safety system governance, aggregate reporting, and inspection readiness; collaborate with cross-functional teams (Regulatory, Medical, Clinical, Quality); support regulatory submissions, safety signal detection, and risk management; drive process standardization and continuous improvement. Requirements: Bachelor's degree in nursing, pharmacy, or related life sciences; 10+ years PV experience in biotech/pharma/CRO settings, with 5+ years in leadership; strong knowledge of global PV regulations (FDA, EMA, ICH, GVP); experience managing PV systems (Argus, ARISg, Veeva); vendor oversight and inspection support skills; US licensure preferred. High-Value: biopharma, gene therapy modalities, clinical development (pre-IND to post-market), safety management, vendor governance, regulatory inspection readiness. Work setup: remote with some travel.