Global Safety Officer

About this role

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: In this role you will be active in five main areas Internal & External Safety Expert • Provide PV and risk management expertise to internal and external customers

• 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 with 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​

Signal Detection & Assessment • 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

Risk Assessment/Risk Management/Benefit-Risk Assessment • 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

Submission Activities • 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

Report Writing • 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 the medical safety expert to the GPE Periodic Reports group for assigned projects and products  

About You Qualifications/Education & Work Experience: • 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) 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

Competencies: • Excellent clinical judgment

• Capability to synthesize and critically analyse 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 are required

• Fluent in English (written and spoken)

Why Choose Us?   • Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• 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 US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.  #GD-SG ​  #LI-GZ  #LI-Hybrid #vhd

Pursue progress , discover extraordinary 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. Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here

US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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 civi

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