Global Safety Officer, I&I
About the role
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?
Sanofi is 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.
Responsibilities
- 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
- Ongoing assessment of the safety status of the product
- Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling
- Review, preparation, and/or contribution to questions from health authorities