Associate Director, PV Case Operations

Role: Associate Director of PV Case Operations overseeing global pharmacovigilance activities, ensuring compliance, and maintaining inspection readiness. Responsibilities: manage case processing deliverables, oversee ICSR quality review, implement quality frameworks, lead root cause analyses, drive CAPA actions, monitor operational metrics and vendor performance, and support audits and inspections. Qualifications: Bachelor's degree (advanced degree preferred), 10+ years in pharmacovigilance/drug safety, extensive knowledge of FDA, EU, and ICH PV regulations, experience managing teams and complex projects. HighValue: pharmacovigilance, drug safety, PV quality, ICSR management, regulatory compliance, audit readiness, global development and marketed products, clinical trial and post-marketing phases, cross-functional collaboration. WorkSetup: onsite in Warren, NJ; Tarrytown, NY; or Cambridge, MA; approximately 25% travel.