Global Safety Officer, I&I

About the Job

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI‑powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. Your skills could be critical in helping our teams accelerate progress.

• Provide PV and risk management expertise to internal and external customers.
• Act as safety expert for product.
• Maintain knowledge of product, product environment, and recent literature.
• Maintain PV expertise and understanding of international safety regulations and guidelines.
• Lead cross‑functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs).
• Communicate and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations.
• Provide strategic and proactive safety input into development plans.
• Support due diligence activities and pharmacovigilance agreements.
• Conduct ongoing assessment of the safety status of the product.
• Review, prepare, contribute to and/or approve clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling.
• Review, prepare, and contribute to questions from health authorities, ethics committees, IRBs, and external partners.
• Manage product safety alerts.
• Ensure the GPE position is well articulated to and understood by its internal and external customers.
• Establish credibility of the GSO function and of GPE.

• Responsible for signal detection and analysis.
• Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group.
• Identify and implement proactive safety analysis strategies to further define the safety profile.
• Lead aggregate safety data review activities and coordinate safety surveillance activities.

• Provide proactive risk assessment.
• Co‑lead benefit‑risk assessment with other relevant functions.
• Develop risk management strategies and plans and monitor effectiveness.
• Collaborate with Center of Excellence for Risk Management and Safety Epidemiology.

• Represent safety position in cross‑functional submission teams.
• Ensure generation, consistency, and quality of safety sections in submission documents.
• Write responses or contributions to health authorities’ questions.
• Support preparation and conduct of Advisory Committee meetings.

• Document, coordinate, review and validate periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report.
• Serve as medical safety expert to the GPE Periodic Reports group for assigned projects and products.

• Excellent clinical judgment.
• Capability to synthesize and critically analyze data from multiple sources.
• Ability to communicate complex clinical issues and analysis orally and in writing.
• Able to develop and document sound risk assessment.
• Demonstrates initiative and capacity to work under pressure.
• Demonstrates leadership within cross‑functional team environment.
• Excellent teamwork and interpersonal skills.
• Fluent in English (written and spoken).

M.D. Degree or equivalent. For MD, Board Certified/Board eligible, or equivalent, is preferred. Minimum 3 years total experience in international pharmacovigilance or equivalent relevant industry experience (e.g., clinical development). Candidates with proven excellence in a similar prior position may be considered even if they have less than 3 years international PV experience.

• Supportive, future‑focused team.
• Opportunities for growth and career advancement.
• Thoughtful rewards package that recognizes your contribution.
• Health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender‑neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, citizenship, marital status, disability, veteran or military status, gender identity or expression, sexual orientation, or any other characteristic protected by law.

$ – $ (commensurate with demonstrated experience). Employees may be eligible to participate in company employee benefit programs.