Aggregate In Pharmacovigilance Jobs in Silver Spring, MD

The Role:

Moderna is seeking a Senior Product Manager - Clinical Safety and Pharmacovigilance Systems to support the digital product strategy, operations, and lifecycle management of the platforms that enable our global Patient Safety and Pharmacovigilance functions. As Product Manager and System Owner, this role will have accountability for system reliability, enhancement delivery, compliance, and long-term technology planning aligned with Moderna's Product Management framework.

This role is essential to ensuring the performance of Moderna's safety systems, including case intake, processing, and aggregate reporting, across the product lifecycle. You will contribute to execute a 3-5 year roadmap, drive adoption of innovative capabilities including AI/ML, and optimize platform performance for stability and cost. The successful candidate will partner closely with stakeholders in Patient Safety, Regulatory, Quality, Clinical Development, and Digital, as well as global teams across the U.S., Poland, and India.

You'll bring deep domain expertise in pharmacovigilance, a strong understanding of GxP-compliant system operations, and a product mindset that prioritizes agility, user-centricity, and innovation. This role contributes directly to Moderna's mission to ensure patient safety and maintain compliance with global health authorities, in alignment with our values of acting with urgency, behaving like owners, and questioning convention.

This role will be based in the US in one of the Moderna Offices. 70% office presence is required.

Here's What You'll Do:

• Serve as System Owner for Clinical Safety and Pharmacovigilance systems, accountable for end-to-end system operations, governance, and lifecycle planning.

• Manage and continuously improve the release management process, including planning, testing, and deployment of new system features and enhancements.

• Ensure full GxP compliance and audit readiness, working in partnership with Quality, IT Compliance, and Regulatory teams.

• Contribute to the definition and delivery of the product strategy and roadmap in alignment with business needs.

• Support execution of the roadmap by coordinating initiatives across functions.

• Support the evaluation and implementation of innovative capabilities such as AI/ML to enhance safety operations.

• Collaborate with agile software squads to develop and deliver custom features and scalable solutions supporting safety operations.

• Contribute domain knowledge to adjacent systems and processes, including regulatory information management and quality compliance systems.

• Proactively challenge existing solutions and workflows, identifying opportunities for simplification, optimization, and innovation.

• Operate effectively in a global, cross-timezone team environment with colleagues and partners in the U.S., Poland, and India.

Here's What You'll Bring to the Table:

• Prior 7+ years' experience in the pharmaceutical or biotechnology industry is required.

• Strong domain expertise in Pharmacovigilance, including safety case processing, aggregate reporting, and post-marketing surveillance.

• Demonstrated product management experience delivering technology solutions in a life sciences or healthcare environment.

• Hands-on experience serving as System Owner for validated GxP systems.

• Solid working knowledge of GxP, GAMP5, and regulatory expectations for computerized systems supporting safety operations.

• Familiarity with Argus Safety, Veeva Vault and other PV ecosystem platforms and integrations.

• Experience working with agile software development teams in a digital product model.

• Ability to collaborate across time zones and cultures; strong cross-functional communication and influence skills.

• A mindset focused on curiosity, ownership, and continuous learning, aligned with Moderna Mindsets.

• Minimal Bachelor's degree in life sciences, computer science, engineering, or a related field required; advanced degree or certifications (e.g., PMP, Agile, GxP systems) are a plus.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, 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 investment opportunities to help you plan for the future

• Location-specific perks and extras

The salary range for this role is $145,900.00 - $234,200.00. 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.

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. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

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

Accommodations

We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

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 leavesandaccommodations@modernatx.com.

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. #LI-CK1

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