Global Safety Officer, Immunology & Inflammation (I&I)
Locations: Morristown, NJ | Cambridge, MA
Salary Range: USD 178,500 – 297,500
Employment Type: Full-Time, Permanent
Experience Level: Senior / Mid-Senior
Experience Required: Minimum 3 years in international pharmacovigilance, or equivalent clinical development experience
About the Role
Sanofi is seeking a highly skilled Global Safety Officer (I&I) to provide strategic pharmacovigilance (PV) leadership and oversee global product safety for Immunology & Inflammation portfolios. This role ensures proactive risk management, signal detection, and compliance with international PV regulations while driving collaboration across cross-functional teams, health authorities, and external stakeholders.
As part of Sanofi’s mission to accelerate innovation in immunology, oncology, neurology, and vaccines, you will help shape the safety strategy for products impacting patients worldwide.
Key Responsibilities
Internal & External Safety Leadership
Act as the PV expert for assigned products, providing guidance on safety, risk management, and benefit-risk evaluation
Lead cross-functional Safety Management Teams (SMTs) and internal Safety Analysis Teams (SATs)
Represent PV positions within project/product teams, regulatory submissions, advisory committees, and external negotiations
Provide strategic safety input to development plans and due diligence activities
Signal Detection & Safety Assessment
Oversee and coordinate signal detection and safety analysis across multiple contributors
Collaborate with Centers of Excellence for Signal Detection, Data Mining, and Safety Epidemiology
Implement proactive safety analysis strategies to optimize benefit-risk profiles
Lead aggregate safety data review and safety surveillance activities
Risk Management & Benefit-Risk Evaluation
Conduct proactive risk assessment and co-lead benefit-risk evaluations with relevant stakeholders
Develop and monitor risk management strategies for effectiveness
Ensure internal and external stakeholders understand the GSO and GPV positions
Regulatory & Submission Activities
Review, prepare, and approve clinical development documents including study protocols, SAPs, investigator brochures, data monitoring plans, study reports, integrated summary of safety, and labeling
Respond to health authorities, ethics committees, IRBs, and external partners
Manage product safety alerts and ensure consistent communication of PV positions
Reporting & Documentation
Coordinate, review, and validate periodic safety reports including RMP updates, IND Annual Reports, DSURs, Development Safety Update Reports, and Periodic Safety Update Reports
Serve as the medical safety expert for assigned products in periodic reporting
Required Qualifications
Education & Credentials
M.D., D.O., or equivalent; Board Certified/Board Eligible preferred
Experience
Minimum 3 years of international pharmacovigilance experience or equivalent clinical development experience
Exceptionally qualified candidates may be considered with less experience if prior PV or clinical safety performance demonstrates excellence
Knowledge & Skills
Strong clinical judgment and expertise in international PV regulations
Ability to synthesize complex data and develop robust risk assessments
Excellent verbal and written communication skills
Leadership and teamwork capabilities in cross-functional, global environments
Fluency in English
Why Join Sanofi
Be part of a leading R&D-driven, AI-powered biopharma organization
Contribute to global patient safety across Immunology & Inflammation portfolios
Access career growth opportunities, international exposure, and leadership development
Competitive compensation and comprehensive benefits including healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave
Work in an inclusive, diverse environment committed to innovation and collaboration
Apply now on thepharmadaily.com to lead global pharmacovigilance initiatives and shape the future of patient safety at Sanofi.
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