Sanofi
biopharma
GlobalSafetyOfficer
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“Global Safety Officer at Sanofi. Skills: pharmacovigilance, risk management, safety evaluation, signal detection, risk assessment, benefit-risk assessment. Provide medical input on the safety evaluation of established drugs and drugs under development. Provide PV and risk management expertise to internal and external customers”
Industry & Context.
Capability to synthesize and critically analyse data from multiple sources; Able to develop and document sound risk assessment
What They're Looking For.
Must Have
M. D. Degree or equivalent, Minimum 3 years' total experience in international pharmacovigilance, or equivalent relevant industry experience (e. g. clinical development) with relevant clinical experience considered, Proven excellence in a similar prior position
Nice to Have
For MD, Board Certifiedoard eligible, or equivalent, is preferred
What You'll Do.
Provide medical input on the safety evaluation of established drugs and drugs under development
Provide PV and risk management expertise to internal and external customers
Safety expert for product
Maintain knowledge of product
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
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
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
and quality of safety sections in submission documents
Write responses or contributions to health authorities’ questions
Support preparation and conduct of Advisory Committee meetings
review and validate Periodic reports
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
How You'll Work.
Team & Collaboration
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; Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group; Co-lead benefit-risk assessment with other relevant functions; Collaborate with Center of Excellence for Risk Management and Safety Epidemiology; Represent safety position in cross functional submission teams; Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products
Communication Scope
Ability to communicate complex clinical issues and analysis orally and in writing; Fluent in English (written and spoken)
Process & Methodology
Lead cross functional Safety Management Teams (SMTs), Lead aggregate safety data review activities, Develop risk management strategies and plans
Full Job Description
**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. _**Context:**_ As a Global Safety Officer in the field of Rare Diseases, you provide medical input on the safety evaluation of established drugs and drugs under development. This will contribute to innovative new therapies which will directly improve the life of patients. **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 safe
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