Associate Director, Pharmacovigilance Operations

Role: Associate Director of Pharmacovigilance (PV) Operations, responsible for overseeing global PV safety activities, vendor governance, and compliance in a biotech oncology setting. Objectives: ensure inspection readiness, regulatory adherence, and scalable PV infrastructure support for clinical and post-market phases. Responsibilities: manage processes for ICSR collection, reconciliation, and reporting; oversee PV vendor activities and KPIs; support regulatory compliance and audit readiness; develop PV SOPs, Safety Management Plans, and Safety Data Exchange Agreements; monitor database configurations and handle deviation/CAPA activities; collaborate cross-functionally with Clinical Ops, Regulatory, Quality, and Medical Affairs; serve as SME in safety governance and external partnerships; manage budgets and vendor contracts. Requirements: 10+ years in PV within biotech/pharma or CRO; degree in Life Sciences, Pharmacy, Nursing, or related field; experience in vendor oversight, safety database management (Argus, ARISg), and global PV regulations (FDA, EMA, MHRA, PMDA, E2B R3); strong leadership, analytical, and stakeholder influence skills; ability to work independently and manage multiple projects in a fast-paced environment. High-Value: deep PV expertise supporting clinical and post-market programs, with emphasis on vendor governance, regulatory compliance, and safety data management across global markets.