Global Safety Officer, I&I
Sanofi
August 16, 2026
Remote friendly (Morristown, NJ)
United States
$178,500 - $297,500 USD yearly
Operations
Main Responsibilities
- Provide PV and risk management expertise to internal and external customers; act as product safety expert
- Maintain knowledge of product, product environment, and recent literature; stay current on international safety regulations and guidelines
- Lead cross-functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs)
- Communicate and represent PV position within project/product teams and with external partners, key opinion leaders, and Health Authorities
- Provide strategic and proactive safety input into development plans
- Support due diligence activities and pharmacovigilance agreements
Impact
- Perform ongoing assessment of product safety status
- Review/prepare/contribute to/approve clinical development documents (e.g., plans, SAPs, protocols, investigator brochures, data monitoring plans, study reports, safety summaries, and labeling)
- Review/prepare/contribute to responses to questions from health authorities, ethics committees/IRBs, and external partners
- Manage product safety alerts; ensure GPE position is understood by customers; establish credibility of GSO/GPE
Signal Detection and Assessment
- Responsible for signal detection and analysis; collaborate with CoE for signal detection/data mining and safety epidemiology
- Implement proactive safety analysis strategies; lead aggregate safety data review and coordinate safety surveillance
Risk Assessment/Risk Management/Benefit-Risk Assessment
- Provide proactive risk assessment; co-lead benefit-risk assessments
- Develop and monitor risk management strategies/plans; collaborate with CoE for risk management and safety epidemiology
Submission Activities
- Represent safety position in cross-functional submission teams; ensure quality of safety sections
- Write/author responses to health authority questions; support Advisory Committee meetings
Report Writing
- Document/coordinate/review/validate periodic reports (e.g., RMP updates and periodic safety updates)
- Serve as medical safety expert to the GPE Periodic Reports group for assigned projects/products
Knowledge and Skills
- Excellent clinical judgment; ability to synthesize/critically analyze multi-source data
- Communicate complex clinical issues orally and in writing; develop and document sound risk assessment
- Initiative and ability to work under pressure; leadership in cross-functional teams; strong teamwork/interpersonal skills
- Fluent in English (written and spoken)
Formal Education and Experience Required
- M.D. or equivalent
- Board Certified/Board eligible (preferred)
- Minimum 3 years total experience in international pharmacovigilance (or equivalent relevant industry experience with clinical experience considered); exceptional candidates may be considered with less than 3 years international PV experience
Benefits
- Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave
- Provide PV and risk management expertise to internal and external customers; act as product safety expert
- Maintain knowledge of product, product environment, and recent literature; stay current on international safety regulations and guidelines
- Lead cross-functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs)
- Communicate and represent PV position within project/product teams and with external partners, key opinion leaders, and Health Authorities
- Provide strategic and proactive safety input into development plans
- Support due diligence activities and pharmacovigilance agreements
Impact
- Perform ongoing assessment of product safety status
- Review/prepare/contribute to/approve clinical development documents (e.g., plans, SAPs, protocols, investigator brochures, data monitoring plans, study reports, safety summaries, and labeling)
- Review/prepare/contribute to responses to questions from health authorities, ethics committees/IRBs, and external partners
- Manage product safety alerts; ensure GPE position is understood by customers; establish credibility of GSO/GPE
Signal Detection and Assessment
- Responsible for signal detection and analysis; collaborate with CoE for signal detection/data mining and safety epidemiology
- Implement proactive safety analysis strategies; lead aggregate safety data review and coordinate safety surveillance
Risk Assessment/Risk Management/Benefit-Risk Assessment
- Provide proactive risk assessment; co-lead benefit-risk assessments
- Develop and monitor risk management strategies/plans; collaborate with CoE for risk management and safety epidemiology
Submission Activities
- Represent safety position in cross-functional submission teams; ensure quality of safety sections
- Write/author responses to health authority questions; support Advisory Committee meetings
Report Writing
- Document/coordinate/review/validate periodic reports (e.g., RMP updates and periodic safety updates)
- Serve as medical safety expert to the GPE Periodic Reports group for assigned projects/products
Knowledge and Skills
- Excellent clinical judgment; ability to synthesize/critically analyze multi-source data
- Communicate complex clinical issues orally and in writing; develop and document sound risk assessment
- Initiative and ability to work under pressure; leadership in cross-functional teams; strong teamwork/interpersonal skills
- Fluent in English (written and spoken)
Formal Education and Experience Required
- M.D. or equivalent
- Board Certified/Board eligible (preferred)
- Minimum 3 years total experience in international pharmacovigilance (or equivalent relevant industry experience with clinical experience considered); exceptional candidates may be considered with less than 3 years international PV experience
Benefits
- Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave