Assistant/Associate Director, Pharmacovigilance Quality Assurance

Role: Assistant/Associate Director, Pharmacovigilance Quality Assurance, leading PV QA activities within development and post-market safety processes. Responsibilities: implement and maintain risk-based GVP-compliant QA programs, conduct and support audits of service providers and internal PV processes, prepare audit reports, ensure inspection readiness, and oversee CAPA effectiveness; provide PV QA guidance, training, and oversight across clinical safety functions; develop quality metrics and support regulatory inspections. Requirements: Bachelor's degree with 8+ years (Assistant Director) or 12+ years (Associate Director) experience in GVP QA or clinical safety; strong GVP audit background, knowledge of global PV regulations (FDA, EMA), GCP, and clinical development; experience supporting inspections and audit management; effective communication and organizational skills; willingness to travel (~10-15%). Preferred: experience with PV service provider oversight, data integrity, and GxP systems. High-value: focus on clinical and post-market PV, global regulatory compliance, audits, inspection readiness, and cross-functional PV support in biotech/pharma settings. Work setup: remote US-based with travel.