Associate Director, PV Operations & Global Compliance

Moderna Therapeutics; Princeton, Northern (NJ, KY); Hybrid; USD 143,000 - 257,000; Full time

Benefits offered by this job

Competitive healthcare

Family planning benefits

Generous paid time off

Savings and investments

Job summary

Moderna is seeking an Associate Director of PV Operations to lead pharmacovigilance excellence across commercial programs and affiliate PV operations. You will oversee framework development for business continuity, regulatory intelligence, and AI-enabled PV initiatives, ensuring global compliance and inspection readiness.

The role requires strong cross-functional collaboration, senior stakeholder engagement, and a proactive approach to PV process improvements and risk management.

Qualifications

• Bachelor’s degree in science or health field; master’s preferred.
• 7+ years 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 inspection readiness.
• Familiarity with digital/AI-enabled pharmacovigilance capabilities.

Responsibilities

• Implement frameworks for commercial programs and country operations to ensure compliance and inspection readiness.
• Establish and maintain affiliate PV standards across geographies.
• Develop KPIs, processes, systems, governance, and compliance controls for PV programs.
• Oversee day-to-day PV program activities and provide fit-for-purpose solutions.
• Lead the BCP process, testing, and act as BCP Lead.
• Manage PV regulatory intelligence activities and implement regulatory requirements into PV processes.
• Lead digital/AI-enabled PV initiatives, including social media monitoring and AE identification.
• Collaborate cross-functionally to ensure a robust PV system and resolve operational risks.
• Identify gaps and drive process improvements in the PV system.

Skills

Pharmacovigilance

Regulatory intelligence

Stakeholder management

Communication

Analytical skills

Education

Bachelor's degree

Master's degree preferred

Tools

PV systems

Social media monitoring tools

Job description

Moderna is seeking an Associate Director of PV Operations to lead pharmacovigilance excellence across commercial programs and affiliate PV operations. You will oversee framework development for business continuity, regulatory intelligence, and AI-enabled PV initiatives, ensuring global compliance and inspection readiness.

The role requires strong cross-functional collaboration, senior stakeholder engagement, and a proactive approach to PV process improvements and risk management.