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Global Safety Officer

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 – Pharmacovigilance

Locations: Morristown, NJ | Cambridge, MA
Employment Type: Full-Time | Permanent
Salary Range: USD 178,500 – 297,500 (commensurate with experience)
Experience Level: Senior / Mid-Senior
Experience Required: Minimum 3 years in international pharmacovigilance or equivalent clinical development experience


Job Overview

Sanofi is seeking an experienced Global Safety Officer to provide strategic pharmacovigilance (PV) expertise and lead global safety management initiatives. The role is pivotal in maintaining and enhancing the safety profile and benefit-risk evaluation of Sanofi’s products across oncology, rare diseases, neurology, and vaccines. You will work collaboratively with internal and external stakeholders, including regulatory authorities, key opinion leaders, and cross-functional teams, to ensure compliance with international safety regulations and drive proactive risk management.


Key Responsibilities

Safety & Pharmacovigilance Leadership

  • Act as the internal and external PV expert for assigned products, providing guidance on safety, risk management, and benefit-risk assessment

  • Lead cross-functional Safety Management Teams (SMTs) and internal Safety Analysis Teams (SATs)

  • Represent PV perspectives within project/product teams, regulatory submissions, and external negotiations

  • Provide strategic, proactive safety input to clinical development plans and due diligence activities

Signal Detection & Assessment

  • Oversee and coordinate signal detection and safety data analysis from multiple contributors

  • Collaborate with Centers of Excellence for Signal Detection, Data Mining, and Safety Epidemiology

  • Implement proactive safety analysis strategies to optimize product benefit-risk profiles

  • Lead aggregate safety data reviews and safety surveillance activities

Risk Management & Benefit-Risk Evaluation

  • Develop and document risk management strategies, monitor effectiveness, and co-lead benefit-risk assessments with relevant functions

  • Ensure the GPV position is clearly communicated and understood by stakeholders

Regulatory & Reporting Support

  • Review, prepare, and contribute to clinical development documents, including protocols, investigator brochures, SAPs, study reports, integrated summaries, and labeling

  • Support responses to regulatory authorities, ethics committees, and external partners

  • Manage product safety alerts and ensure compliance with global PV guidelines


Required Qualifications

Education & Credentials

  • M.D., D.O., or equivalent

  • Board Certified or Board Eligible preferred

Experience

  • Minimum 3 years of international pharmacovigilance experience or equivalent clinical development experience

  • Exceptional candidates with proven prior success in PV roles may be considered even if they have less than 3 years of international experience

Knowledge & Skills

  • Strong clinical judgment and the ability to synthesize complex data from multiple sources

  • Expertise in international PV regulations and safety guidelines

  • Proficient in documenting risk assessments and communicating safety data effectively

  • Excellent teamwork, leadership, and interpersonal skills

  • Fluency in English, both written and spoken


Why Join Sanofi

  • Work at the forefront of biopharmaceutical innovation, blending immunoscience with AI-driven research

  • Drive global safety strategy and have a direct impact on patient outcomes

  • Access opportunities for career growth, international exposure, and leadership development

  • Competitive total rewards package, including healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave

  • Join an inclusive workplace that values diversity, equity, and innovation


Apply now on thepharmadaily.com to lead global pharmacovigilance and ensure Sanofi products maintain the highest standards of patient safety and regulatory compliance.