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 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 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. #J-18808-Ljbffr