Job Title: Global Safety Officer
Location: Cambridge, MA, Morristown, NJ
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.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities:
1. Provide PV and risk management expertise to internal and external customers
2. Safety expert for product
3. Maintain knowledge of product, product environment, and recent literature
4. Maintain PV expertise, and understanding of international safety regulations and guidelines
5. Lead cross functional Safety Management Teams (SMTs)
6. Communicate with and represent PV analyses and PV position within project/product teams, in safety governance and benefit-risk governance activities and committees (e.g. Safety Management Committee, Benefit-Risk Assessment Committee), with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations
7. Provide strategic and proactive safety input into development plans
8. Support due diligence activities and pharmacovigilance agreements
Signal Detection & Assessment
9. Responsible for signal detection and analysis
10. Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
11. Identify and implement proactive safety analysis strategies to further define the safety profile
12. Lead aggregate safety data review activities and coordinate safety surveillance activities
Risk Assessment & Risk Management & Benefit-Risk Assessment
13. Provide proactive risk assessment
14. Co-lead benefit-risk assessment with other relevant functions
15. Develop risk management strategies and plans and monitor effectiveness
16. Collaborate with Center of Excellence for Risk Management and Epidemiology/Benefit-Risk groups
Submission Activities
17. Represent safety position in cross functional submission teams
18. Ensure generation, consistency, and quality of safety sections in submission documents
19. Write responses or contributions to health authorities’ questions
20. Support preparation and conduct of Advisory Committee meetings
Report Writing
21. Document, contribute to, coordinate, review and/or validate Periodic Reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report
22. Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products
About You
Knowledge & Skills
23. Excellent clinical judgment
24. Capability to synthesize and critically analyze data from multiple sources
25. Ability to communicate complex clinical issues and analysis orally and in writing
26. Able to develop and document sound risk assessment
27. Demonstrates initiative and capacity to work under pressure
28. Demonstrates leadership within cross-functional team environment
29. Excellent teamwork and interpersonal skills are required
30. Fluent in English (written and spoken)
Formal Education & Experience Required
31. M.D. Degree
32. Board Certified/Board eligible, or equivalent, is preferred
33. Minimum 3 years total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered. Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience
Why Choose Us?
34. Bring the miracles of science to life alongside a supportive, future-focused team.
35. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
36. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
37. Take good care of yourself and your family, with a wide range of 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 diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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Pursue, discover
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our and check out our Diversity Equity and Inclusion actions at !
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; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
The salary range for this position is:
$178,500.00 - $297,500.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the .