Global Safety Officer, I&I
Sanofi
August 16, 2026
Remote friendly (Cambridge, MA)
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.
- 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).
- Represent PV position in project/product teams, with external partners, key opinion leaders, Health Authorities, and during negotiations.
- Provide strategic and proactive safety input into development plans.
- Support due diligence activities and pharmacovigilance agreements.
Signal Detection and Assessment
- Responsible for signal detection and analysis.
- Collaborate with Center of Excellence for Signal Detection and 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 assessment with relevant functions.
- Develop and monitor effectiveness of risk management strategies and plans.
Submission, Reporting, and Communication
- Represent safety position in cross-functional submission teams; ensure safety sections are consistent and high quality.
- Write responses/contributions to health authorities’ questions.
- Support Advisory Committee meetings.
- Document, coordinate, review, and validate periodic reports (e.g., RMP updates, IND Annual Report, Annual/Periodic Safety Update reports).
Knowledge and Skills
- Excellent clinical judgment; synthesize and critically analyze data from multiple sources.
- Communicate complex issues orally and in writing; develop and document sound risk assessments.
- Initiative, ability to work under pressure; leadership, teamwork, and interpersonal skills.
- Fluent in English.
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 such as clinical development); exceptional consideration possible with proven excellence in a similar prior position.
Benefits (explicitly stated)
- 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.
- 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).
- Represent PV position in project/product teams, with external partners, key opinion leaders, Health Authorities, and during negotiations.
- Provide strategic and proactive safety input into development plans.
- Support due diligence activities and pharmacovigilance agreements.
Signal Detection and Assessment
- Responsible for signal detection and analysis.
- Collaborate with Center of Excellence for Signal Detection and 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 assessment with relevant functions.
- Develop and monitor effectiveness of risk management strategies and plans.
Submission, Reporting, and Communication
- Represent safety position in cross-functional submission teams; ensure safety sections are consistent and high quality.
- Write responses/contributions to health authorities’ questions.
- Support Advisory Committee meetings.
- Document, coordinate, review, and validate periodic reports (e.g., RMP updates, IND Annual Report, Annual/Periodic Safety Update reports).
Knowledge and Skills
- Excellent clinical judgment; synthesize and critically analyze data from multiple sources.
- Communicate complex issues orally and in writing; develop and document sound risk assessments.
- Initiative, ability to work under pressure; leadership, teamwork, and interpersonal skills.
- Fluent in English.
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 such as clinical development); exceptional consideration possible with proven excellence in a similar prior position.
Benefits (explicitly stated)
- High-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.