Job Title: Global Safety Officer – Oncology
Company: Sanofi
Locations: Cambridge, MA | Morristown, NJ
Salary Range: USD 172,500 – 287,500 per year
Employment Type: Full-time | Onsite
Department: Global Pharmacovigilance & Epidemiology (GPE)
About Sanofi
At Sanofi, we’re driven by one purpose — to chase the miracles of science to improve people’s lives.
Join a global healthcare leader where innovation, collaboration, and growth opportunities come together. Work at the intersection of immunoscience, AI-powered discovery, and cutting-edge oncology research to deliver real-world impact.
Position Overview
As a Global Safety Officer (GSO) – Oncology, you’ll serve as the internal and external expert on product safety and pharmacovigilance.
You will lead safety strategy, risk management, signal detection, and safety data evaluation across oncology products, ensuring patient safety and regulatory compliance worldwide.
Key Responsibilities
1. Internal & External Safety Expertise
Provide pharmacovigilance (PV) and risk management expertise to internal and external stakeholders.
Serve as the safety expert for assigned oncology products.
Maintain deep knowledge of the product, environment, and current literature.
Lead cross-functional Safety Management Teams (SMTs) and Safety Analysis Teams (SATs).
Represent the PV position with project teams, regulatory agencies, partners, and health authorities.
Contribute proactively to development plans and due diligence activities.
2. Signal Detection & Assessment
Lead signal detection, data analysis, and safety surveillance activities.
Collaborate with Centers of Excellence for Signal Detection, Data Mining, and Safety Epidemiology.
Develop proactive safety analysis strategies and safety action plans.
Ensure timely communication of risk-benefit evaluations and labeling updates.
3. Risk Assessment & Risk Management
Conduct benefit-risk assessments and design risk management strategies (RMP, REMS, DRMP).
Collaborate cross-functionally to monitor and evaluate risk mitigation tools.
Ensure regulatory compliance and documentation of risk management effectiveness.
4. Regulatory Submissions
Represent the safety function in submission teams.
Ensure quality and consistency of safety data in regulatory documents.
Prepare or review responses to Health Authority (HA) questions.
Support Advisory Committee meetings and safety-related sections of submission dossiers.
5. Report Writing
Lead or review Periodic Safety Reports (PSUR, DSUR, RMP updates) and related documentation.
Serve as the medical safety expert for periodic reporting and product-specific safety evaluation.
Impact Areas
Continuous safety evaluation of assigned products.
Clear articulation of GPE positions within the organization.
Strong cross-functional leadership and safety governance.
Effective risk communication and proactive risk management.
Qualifications
Education
M.D. degree (required) or equivalent qualification.
Board Certification/Eligibility preferred.
Experience
Minimum 3 years of international pharmacovigilance or equivalent experience in clinical development.
Proven expertise in drug safety, risk management, and regulatory communication.
Exceptional candidates with relevant prior experience may be considered with less PV experience.
Skills & Competencies
Excellent clinical judgment and data interpretation skills.
Strong oral and written communication abilities.
Leadership experience in cross-functional environments.
Analytical mindset with capability to handle complex safety data.
Fluent in English (written and spoken).
Why Join Sanofi?
Work alongside a global, inclusive, and diverse team that values innovation.
Enjoy career growth opportunities through promotions or global assignments.
Receive a comprehensive rewards package, including:
Competitive compensation
High-quality healthcare benefits
Wellness and prevention programs
14 weeks of gender-neutral parental leave
Equal Opportunity Statement
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action Employers committed to a culturally diverse workforce.
All qualified applicants will receive consideration regardless of race, color, creed, religion, sex, age, national origin, gender identity, sexual orientation, disability, veteran status, or other protected characteristics.
How to Apply
🔹 Click “Apply Now” on the official Sanofi careers page.
🔹 Learn more about our culture by watching “One Day at Sanofi” and exploring our Diversity, Equity & Inclusion initiatives at sanofi.com.
Tags
#Pharmacovigilance #OncologySafety #DrugSafety #GlobalSafetyOfficer #Sanofi #ClinicalSafety #RiskManagement #PVJobs
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