Associate Director, PV Operations, PV Center of Excellence Moderna is seeking an Associate Director, PV Operations, PV Center of Excellence, responsible for supporting Moderna's Pharmacovigilance Quality Management System through oversight of commercial programs, affiliate PV standards, business continuity, PV regulatory intelligence, digital and AI-enabled pharmacovigilance solutions, and inspection readiness. This role will implement PV strategies and process standards across the PV system to support compliance, standardization, patient safety, and operational excellence as Moderna continues to advance its commercial portfolio. The Associate Director will work closely with cross-functional partners across Moderna to deliver strategic PV initiatives and ensure continued compliance with the PV system.
Here's What You'll Do:- Implement and manage frameworks for commercial programs, including PSPs, MRPs, digital initiatives, business continuity, and country operations to support pharmacovigilance compliance and inspection readiness.
- Establish and maintain affiliate PV standards and country operations frameworks to support consistent implementation of PV requirements across geographies.
- Implement commercial program oversight mechanisms through development of relevant KPIs, processes, systems, governance, and compliance controls.
- Manage day-to-day activities related to commercial programs and provide expertise and fit-for-purpose solutions for these programs.
- Drive the BCP process, manage testing, and function as the BCP Lead.
- Oversee and execute PV regulatory intelligence activities, including monitoring, assessment, impact analysis, and implementation of applicable global regulatory requirements into PV processes, procedures, and operational controls.
- Lead and execute digital and AI-enabled pharmacovigilance initiatives, including social media monitoring capabilities, to support adverse event identification, quality controls, regulatory compliance, and patient safety.
- Collaborate with PV functional areas and stakeholders across Pharmacovigilance, Quality, Global Regulatory Sciences, Clinical Development, Medical Affairs, Commercial, Digital, senior leadership, and regional teams to help ensure a robust pharmacovigilance system at Moderna.
- Partner cross-functionally to deliver PV initiatives, resolve operational risks, and support inspection readiness.
- Identify gaps and areas for improvement within the PV system.
- Initiate and lead process improvements, including creation and updates of relevant PV procedures.
- Define and implement strategies and action plans for identifying and managing risks across the PV system and geographies on an ongoing basis.
- Lead and implement regulatory and PV systems and other infrastructure evolution, as assigned.
- Support establishment of a robust local PV system in collaboration with Heads of Regions.
- Build strong, open, and collaborative working relationships with internal and external stakeholders and matrixed project teams.
- Maintain up-to-date knowledge of global regulatory requirements and industry expectations to inform PV process improvements, inspection readiness, and compliance strategy.
- Lead internal and external interactions to ensure quality, compliance, and standardization.
- Provide input into business strategy as it relates to compliance and policy.
- Engage externally to support ongoing benchmarking and leverage best practices.
- Collaborate cross-functionally to foster a culture of compliance and quality, with a first-time-right mindset.
- Perform other duties and responsibilities as assigned to support PV Operations, CSPV priorities, and evolving business needs.
- Here's What You'll Bring to the Table:
- 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.
- Strong communication, influencing, and stakeholder management skills, with the ability to partner effectively across functions, regions, and levels of management.
- Excellent interpersonal, conflict management, and negotiation skills, with the ability to build trusted relationships, escalate issues appropriately, and develop practical recommendations.
- Excellent analytical skills and ability to communicate complex issues clearly and propose solutions.
- Ability to manage multiple, complex projects in a fast-paced environment.
Pay & Benefits:- At Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
- Competitive healthcare, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investments to help you plan for the future
- Location-specific perks and extras
The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
