Associate Director, PV Operations & Digital Compliance

Moderna Therapeutics; West Windsor (NJ); On-site; USD 143,000 - 257,000; Full time

Job summary

Moderna is seeking an Associate Director, PV Operations, PV Center of Excellence to oversee the Pharmacovigilance Quality Management System and ensure compliance across the PV network. You will implement PV strategies, manage cross‑functional programs, and drive inspection readiness by establishing standards, controls, and governance across geographies.

The role requires a strong background in pharmacovigilance, regulatory intelligence, and digital/AI‑enabled safety solutions, with collaboration

Qualifications

• Bachelor’s degree, preferably in a science or health‑related field; master’s degree preferred.
• A minimum of 7 years of experience in pharmacovigilance, including experience supporting commercial products and/or affiliate PV operations.
• Strong knowledge of global PV regulations, regulatory intelligence processes, and application of regulatory requirements within PV systems and procedures.
• Experience with commercial PV programs, PV controls, governance, and compliance mechanisms preferred.
• Familiarity with digital, automation, or AI‑enabled pharmacovigilance capabilities, including social media monitoring and adverse event identification, preferred.
• Experience supporting Health Authority inspection preparation, interviews, response processes, and inspection management.

Responsibilities

• Implement and manage frameworks for commercial programs to support pharmacovigilance compliance and inspection readiness.
• Establish and maintain affiliate PV standards and country operations frameworks across geographies.
• Develop KPIs, processes, systems, governance, and controls for oversight of commercial programs.
• Manage day‑to‑day activities related to commercial programs and provide fit‑for‑purpose solutions.
• Drive the business continuity planning (BCP) process, testing, and lead the BCP team.
• Lead PV regulatory intelligence activities, assessing impacts and integrating requirements into PV processes.
• Lead digital and AI‑enabled PV initiatives, including social media monitoring for safety signals.
• Collaborate across PV, Quality, Regulatory, Clinical Development, Medical Affairs, and regions to ensure a robust PV system.
• Identify gaps, drive process improvements, and implement PV procedures.
• Support establishment of a robust local PV system with Heads of Regions.

Skills

Pharmacovigilance

Regulatory intelligence

Digital pharmacovigilance

Cross-functional collaboration

Communication

Stakeholder management

Education

Bachelor's degree in science/health field

Master's degree preferred

Job description

Moderna is seeking an Associate Director, PV Operations, PV Center of Excellence to oversee the Pharmacovigilance Quality Management System and ensure compliance across the PV network. You will implement PV strategies, manage cross‑functional programs, and drive inspection readiness by establishing standards, controls, and governance across geographies.

The role requires a strong background in pharmacovigilance, regulatory intelligence, and digital/AI‑enabled safety solutions, with collaboration