Senior Product Manager, Clinical Safety and Pharmacovigilance Systems

Moderna Theraputics • Massachusetts, MA

70d • Onsite

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 5,001-10,000 employees