Senior Pharmacovigilance Systems Product Manager

RXinsider LTD.; Cambridge (MA); Hybrid; USD 146,000 - 234,000; Full time

Benefits offered by this job

Best-in-class healthcare coverage

Well-being programs

Family planning benefits

Paid time off including vacation and 2

Savings and investment opportunities

Location-specific perks

Job summary

Moderna is seeking a Senior Product Manager – Clinical Safety and Pharmacovigilance Systems to drive digital product strategy, operations, and lifecycle management for global Patient Safety platforms. As System Owner, you’ll ensure reliability, compliance, and long‑term planning aligned with Moderna’s framework.

You will guide the roadmap, adopt innovative capabilities including AI/ML, and optimize platform performance.

Qualifications

• Minimum 7+ years in the pharmaceutical/biotechnology industry.
• Strong PV domain expertise including safety case processing and reporting.
• Product management experience delivering tech solutions in life sciences.
• Hands-on System Owner for validated GxP systems.
• Knowledge of GxP, GAMP5, and regulatory expectations for safety ops.
• Experience with PV ecosystems and PV tech integrations.
• Experience working with agile software teams and cross-timezone collaboration.
• Bachelor’s degree in related field; advanced degree or certs are a plus.

Responsibilities

• Serve as System Owner for Clinical Safety and Pharmacovigilance systems and lifecycle planning.
• Manage release management processes including planning, testing, deployment.
• Ensure GxP compliance and audit readiness with Quality, IT Compliance, Regulatory.
• Contribute to product strategy and roadmap aligned with business needs.
• Coordinate cross-functional initiatives to execute the roadmap.
• Evaluate and implement AI/ML capabilities to enhance safety ops.
• Collaborate with agile squads to deliver scalable safety solutions.
• Share domain knowledge with adjacent systems like regulatory information management.
• Proactively identify simplifications and process optimizations.
• Operate effectively in a global team across the U.S., Poland, and India.

Skills

Pharmacovigilance

Product management

GxP systems

Agile teams

Cross-timezone collaboration

PV system owner

Education

Bachelor's degree in life sciences / CS / engineering

Advanced degree or certifications (PMP, Agile, GxP)

Tools

Argus Safety

Veeva Vault

Job description

Moderna is seeking a Senior Product Manager – Clinical Safety and Pharmacovigilance Systems to drive digital product strategy, operations, and lifecycle management for global Patient Safety platforms. As System Owner, you’ll ensure reliability, compliance, and long‑term planning aligned with Moderna’s framework.

You will guide the roadmap, adopt innovative capabilities including AI/ML, and optimize platform performance.