Associate Director, PV Operations, PV Center of Excellence

Role: Associate Director of Pharmacovigilance (PV) Operations at Moderna, focusing on PV system quality management, compliance, and inspection readiness for commercial products. Responsibilities include implementing PV frameworks across global programs, establishing affiliate PV standards, managing digital and AI-enhanced pharmacovigilance initiatives, overseeing regulatory intelligence, and supporting inspection processes. The role requires collaboration with cross-functional teams across PV, Quality, Regulatory, Medical, and Commercial functions to maintain a robust PV system, drive process improvements, and ensure adherence to evolving global PV regulations. Qualifications include a Bachelor’s degree (Master’s preferred), at least 7 years of PV experience supporting commercial products, and strong knowledge of PV regulations, controls, and compliance. Experience with digital, automation, or AI tools in PV, and familiarity with inspection management are desirable. The position emphasizes stakeholder management, analytical skills, and the ability to manage multiple projects in a fast-paced environment. The role is based on-site with a hybrid work model, with some travel expected. High-value specifics include focus on global PV standards, inspection readiness, digital PV solutions, and supporting Moderna’s expanding commercial portfolio.