Senior Product Manager, Clinical Safety and Pharmacovigilance Systems

Role Summary

Senior Product Manager – Clinical Safety and Pharmacovigilance Systems responsible for the digital product strategy, operations, and lifecycle management of platforms supporting global Patient Safety and Pharmacovigilance. Acts as Product Manager and System Owner with accountability for system reliability, enhancements, compliance, and long-term technology planning. Based in the US with 70% in-office presence.

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.

Qualifications

• Required: 7+ years of experience in the pharmaceutical or biotechnology industry.
• 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 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.
• Curiosity, ownership, and continuous learning mindset aligned with Moderna Mindsets.
• Minimum Bachelor's degree in life sciences, computer science, engineering, or related field; advanced degree or certifications (e.g., PMP, Agile, GxP systems) a plus.

Skills

• Pharmacovigilance domain expertise
• GxP systems and regulatory compliance
• Product management across life sciences software
• System ownership and governance
• Aggressive collaboration and stakeholder management
• AI/ML for safety operations (desirable)