Associate Director, PV Operations & Compliance Excellence

BioSpace; Princeton (NJ); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Healthcare

Well-being programs

Family planning benefits

Generous PTO

Equity eligibility

Job summary

Moderna is seeking an Associate Director, PV Operations, PV Center of Excellence to oversee the Pharmacovigilance Quality Management System across commercial programs and affiliates. The role focuses on implementing PV strategies, ensuring inspection readiness, and driving data-driven improvements with digital and AI-enabled PV capabilities.

The candidate will partner across PV, Quality, Regulatory Science, Clinical Development, Medical Affairs, and regional teams to maintain a robust PV system,

Qualifications

• 7+ years of experience in pharmacovigilance, including commercial products or affiliate PV operations.
• Strong knowledge of global PV regulations and regulatory intelligence processes.
• Experience with PV controls, governance, and compliance mechanisms.
• Familiarity with digital, automation, or AI-enabled PV capabilities.

Responsibilities

• Implement PV frameworks for commercial programs, affiliate operations, and country frameworks.
• Develop KPIs, processes, systems, governance, and compliance controls for PV activities.
• Lead PV regulatory intelligence activities and integrate requirements into PV processes.
• Drive digital and AI-enabled PV initiatives, including social media monitoring for AE signals.
• Collaborate cross-functionally to ensure robust PV system, inspection readiness, and risk mitigation.
• Identify gaps, lead process improvements, and manage multi-geography PV strategies.

Skills

Pharmacovigilance

Regulatory intelligence

Digital/AI PV

Inspection readiness

Cross-functional collaboration

Education

Bachelor's degree in science/health

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 across commercial programs and affiliates. The role focuses on implementing PV strategies, ensuring inspection readiness, and driving data-driven improvements with digital and AI-enabled PV capabilities.

The candidate will partner across PV, Quality, Regulatory Science, Clinical Development, Medical Affairs, and regional teams to maintain a robust PV system,