Global PV Safety Systems Product Leader

BioSpace; Cambridge (MA); Hybrid; USD 146,000 - 234,000; Full time

Job summary

Moderna seeks a Senior Product Manager – Clinical Safety and Pharmacovigilance Systems to drive the digital product strategy, operations, and lifecycle management of platforms enabling global Patient Safety and Pharmacovigilance functions. You will own system reliability, roadmap execution, and compliance across the product lifecycle, partnering with stakeholders in the US and internationally.

This role requires 70% in-office presence in Moderna offices and a strong emphasis on agility and

Qualifications

• 7+ years' experience in the pharmaceutical or biotechnology industry.
• Deep PV domain expertise including safety case processing and aggregate reporting.
• Product management experience delivering technology solutions in life sciences or healthcare.
• Hands-on System Owner for validated GxP systems.
• Solid working knowledge of GxP, GAMP5, and regulatory expectations for computerized systems.
• Familiarity with PV ecosystem platforms (Argus Safety, Veeva Vault) and integrations.
• Experience with agile software development teams in a digital product model.
• Strong cross-functional communication and influence across time zones.
• Bachelor's degree required; advanced degree or certifications (e.g., PMP, Agile, GxP) a plus.

Responsibilities

• Own end-to-end system operations, governance, and lifecycle planning for Clinical Safety and Pharmacovigilance systems.
• Manage release planning, testing, and deployment of new features and enhancements.
• Ensure GxP compliance and audit readiness with Quality, IT Compliance, and Regulatory teams.
• Contribute to definition and delivery of product strategy and roadmap in line with business needs.
• Coordinate initiatives across functions to support roadmap execution.
• Evaluate and implement AI/ML to enhance safety operations.
• Collaborate with agile squads to deliver scalable safety features.
• Share domain knowledge with regulatory and quality systems.
• Proactively challenge existing solutions and workflows to simplify and innovate.
• Operate in a global, cross-timezone team with colleagues in the U.S., Poland, and India.

Skills

Pharmacovigilance domain expertise

Product management experience

System Owner for GxP systems

Agile software development

Cross-functional collaboration

Global time-zone collaboration

Education

Bachelor's degree in Life Sciences / CS / Engineering

Tools

Argus Safety

Veeva Vault

PV integrations

Job description

Moderna seeks a Senior Product Manager – Clinical Safety and Pharmacovigilance Systems to drive the digital product strategy, operations, and lifecycle management of platforms enabling global Patient Safety and Pharmacovigilance functions. You will own system reliability, roadmap execution, and compliance across the product lifecycle, partnering with stakeholders in the US and internationally.

This role requires 70% in-office presence in Moderna offices and a strong emphasis on agility and