Jobs · Marketing · Massachusetts

Senior Product Manager, Clinical Safety and Pharmacovigilance Systems

Moderna · Cambridge, MA · 3 wk ago
Marketing$146k–$234k/yrFull-time

About the role

The Role 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.

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.
  • Contribute to 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.

Requirements

  • To qualify, candidates must have prior 7+ years’ 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 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.

Qualifications

  • 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.

Skills

  • Deep domain expertise in pharmacovigilance, including safety case processing, aggregate reporting, and post-marketing surveillance.
  • Strong understanding of GxP-compliant system operations.
  • Product mindset that prioritizes agility, user-centricity, and innovation.

Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. 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.

Pay & Benefits

The salary range for this role is $145,900.00 - $234,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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