Global Safety Officer

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.

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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.

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 ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

US and Puerto Rico Residents Only

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.

North America Applicants Only

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 LINK .