Global Safety Officer

## Global Safety Officer Bewerbenlocations:
Cambridge, MA:
Morristown, NJtime type:
Vollzeitposted on:
Heute ausgeschriebentime left to apply:
Enddatum:
4. September 2026 (Noch 30+ Tage Zeit für Bewerbung) job requisition :
R2857065
*
* Job title:

** Global Safety Officer
** Grade:
** L4
* * Hiring manager:
** Swathi Tammireddy
*
* 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,…