Sanofi
healthcare
GlobalSafetyOfficer,I&I
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Global Safety Officer, I&I at Sanofi. Skills: Internal & External Safety Expert, Signal Detection and Assessment, Risk Assessment/Risk Management/ Benefit-Risk Assessment, Submission Activities, Report Writing. Provide PV and risk management expertise to internal and external customers. Safety expert for product”
What You'll Achieve.
Ongoing assessment of the safety status of the product; Identify and implement proactive safety analysis strategies to further define the safety profile.; Develop risk management strategies and plans and monitor effectiveness
Industry & Context.
Capability to synthesize and critically analyze data from multiple sources
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
Board Certifiedoard eligible, or equivalent
What You'll Do.
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
Ongoing assessment of the safety status of the product
contribution and/or approval of clinical development documents including clinical development plans
investigator brochures
data monitoring plans
integrated summary of safety
summary of clinical safety
and/or contribution to questions from health authorities
Management of product safety alerts
Ensuring the GPE position is well articulated to and understood by its internal and external customers
Establishment of credibility of GSO function and of GPE
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); 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
Communication Scope
Ability to communicate complex clinical issues and analysis orally and in writing
Full Job Description
**Job title:** Global Safety Officer, I&I **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. Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? **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:_** **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 pharmaco
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