Associate Director, PV Operations, PV Center of Excellence

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

The Role:

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, elevate 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

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.

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world‑class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Our Working Model

As we build our company, we have always believed an in‑person culture is critical to our success. Moderna champions the significant benefits of in‑office collaboration by embracing a 70/30 work model. This 70% in‑office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Healthy Workplace

Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

Moderna is a place where everyone can grow.

Moderna is an E‑Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [e-mail].

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export‑controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non‑U.S. persons to apply for an export control license.

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [e-mail] if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.