Global Safety Officer, I&I

Summary

Job title: Global Safety Officer, I&ILocation: Cambridge, MA / Morristown, NJAbout The JobJoin the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll 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 peoples lives. Were 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 SanofiWere an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples lives.Main ResponsibilitiesInternal & External Safety Expert:Provide PV and risk management expertise to internal and external customersSafety expert for productMaintain knowledge of product, product environment, and recent literatureMaintain PV expertise, and understanding of international safety regulations and guidelinesLead 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 negotiationsProvide strategic and proactive safety input into development plansSupport due diligence activities and pharmacovigilance agreementsImpactOngoing assessment of the safety status of the productReview, 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 labelingReview, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partnersManagement of product safety alertsEnsuring the GPE position is well articulated to and understood by its internal and external customersEstablishment of credibility of GSO function and of GPESignal Detection And AssessmentResponsible for signal detection and analysisCollaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology groupIdentify and implement proactive safety analysis strategies to further define the safety profile.Lead aggregate safety data review activities and coordinate safety surveillance activitiesRisk Assessment/Risk Management/ Benefit-Risk AssessmentProvide proactive risk assessmentCo-lead Benefit-risk Assessment With Other Relevant FunctionsDevelop risk management strategies and plans and monitor effectivenessCollaborate with Center of Excellence for Risk Management and Safety EpidemiologySubmission ActivitiesRepresent safety position in cross functional submission teamsEnsure generation, consistency, and quality of safety sections in submission documentsWrite responses or contributions to health authorities questionsSupport preparation and conduct of Advisory Committee meetingsReport WritingDocument, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update ReportServe as the medical safety expert to the GPE Periodic Reports group for assigned projects and products.About YouKnowledge and Skills:Excellent clinical judgmentCapability to synthesize and critically analyze data from multiple sourcesAbility to communicate complex clinical issues and analysis orally and in writingAble to develop and document sound risk assessmentDemonstrates initiative and capacity to work under pressureDemonstrates leadership within cross-functional team environmentExcellent Teamwork And Interpersonal Skills Are RequiredFluent in English (written and spoken).Formal Education And Experience RequiredM.D. Degree or equivalent.For MD, Board Certified/Board eligible, or equivalent, is preferredFor M.D., 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.Why Choose UsBring the miracles of science to life alongside a supportive, future-focused team.Discover endless opportunities to grow your talent and drive your career, whether its 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.Equal OpportunitySanofi 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.Salary Range$178,500.00 - $297,500.00All 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.All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.#J-18808-Ljbffr

Job Description

Job title: Global Safety Officer, I&ILocation: Cambridge, MA / Morristown, NJAbout The JobJoin the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll 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 peoples lives. Were 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 SanofiWere an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples lives.Main ResponsibilitiesInternal & External Safety Expert:Provide PV and risk management expertise to internal and external customersSafety expert for productMaintain knowledge of product, product environment, and recent literatureMaintain PV expertise, and understanding of international safety regulations and guidelinesLead 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 negotiationsProvide strategic and proactive safety input into development plansSupport due diligence activities and pharmacovigilance agreementsImpactOngoing assessment of the safety status of the productReview, 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 labelingReview, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partnersManagement of product safety alertsEnsuring the GPE position is well articulated to and understood by its internal and external customersEstablishment of credibility of GSO function and of GPESignal Detection And AssessmentResponsible for signal detection and analysisCollaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology groupIdentify and implement proactive safety analysis strategies to further define the safety profile.Lead aggregate safety data review activities and coordinate safety surveillance activitiesRisk Assessment/Risk Management/ Benefit-Risk AssessmentProvide proactive risk assessmentCo-lead Benefit-risk Assessment With Other Relevant FunctionsDevelop risk management strategies and plans and monitor effectivenessCollaborate with Center of Excellence for Risk Management and Safety EpidemiologySubmission ActivitiesRepresent safety position in cross functional submission teamsEnsure generation, consistency, and quality of safety sections in submission documentsWrite responses or contributions to health authorities questionsSupport preparation and conduct of Advisory Committee meetingsReport WritingDocument, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update ReportServe as the medical safety expert to the GPE Periodic Reports group for assigned projects and products.About YouKnowledge and Skills:Excellent clinical judgmentCapability to synthesize and critically analyze data from multiple sourcesAbility to communicate complex clinical issues and analysis orally and in writingAble to develop and document sound risk assessmentDemonstrates initiative and capacity to work under pressureDemonstrates leadership within cross-functional team environmentExcellent Teamwork And Interpersonal Skills Are RequiredFluent in English (written and spoken).Formal Education And Experience RequiredM.D. Degree or equivalent.For MD, Board Certified/Board eligible, or equivalent, is preferredFor M.D., 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.Why Choose UsBring the miracles of science to life alongside a supportive, future-focused team.Discover endless opportunities to grow your talent and drive your career, whether its 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.Equal OpportunitySanofi 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.Salary Range$178,500.00 - $297,500.00All 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.All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.#J-18808-Ljbffr