Senior Product Manager, Clinical Safety and Pharmacovigilance Systems

Serve as System Owner for Clinical Safety and Pharmacovigilance systems, managing end-to-end operations, governance, and lifecycle planning.,Manage and 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.

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.

Bachelor's Degree

70% office presence is required.,Employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law.,Only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.,Moderna is unable to sponsor non-U.S. persons to apply for an export control license for this role.