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Global Safety Officer, I&I

Sanofi
Sanofi
3 years
preferred by company
10 Jan. 15, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.