Director, PV Operational Excellence

Role: Lead pharmacovigilance quality oversight for biopharma products, ensuring compliance across the product lifecycle. Responsibilities: develop PV quality strategies, manage CAPAs, oversee vendor and system validation, lead inspection readiness, and collaborate on training and regulatory monitoring. Qualifications: 12+ years PV experience, advanced scientific degree preferred, strong knowledge of global safety regulations (FDA, EMA, ICH), proficiency with safety databases (Argus, Veeva), MedDRA, and vendor management. HighValue: PV quality systems, vendor oversight, global compliance, inspection readiness, and regulatory intelligence. WorkSetup: office-based in Waltham, MA, with up to 15% travel.