Moderna · 1 hour ago
Senior Product Manager, Clinical Safety and Pharmacovigilance Systems
Cambridge, MA
Full-time
Onsite
Senior Level
$146K/yr - $234K/yr
7+ years expModerna is a biotechnology company focused on mRNA technology. They are seeking a Senior Product Manager to oversee the digital product strategy and lifecycle management of platforms that support Patient Safety and Pharmacovigilance functions, ensuring system reliability and compliance.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
No H1B
U.S. Citizen Only
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
Qualification
Required
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
Preferred
Advanced degree or certifications (e.g., PMP, Agile, GxP systems) are a plus
Benefits
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
Company
Moderna
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M
Leadership Team
Stephane Bancel
Founding CEO
Kenneth Chien
Co-Founder
Recent News
2025-12-30
The Motley Fool
2025-12-27
2025-12-22
Company data provided by crunchbase