Global Safety Officer, Rare Diseases

3+ years

USD 172,500.00 - 287,500.00

United States

10 Oct. 27, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧠 Job Title: Global Safety Officer – Rare Diseases

📍 Location:

Morristown, New Jersey
Cambridge, Massachusetts

💰 Salary Range: USD 172,500 – 287,500

🏢 Company: Sanofi

🌍 About the Company

At Sanofi, we are an innovative global healthcare company driven by one purpose — to chase the miracles of science to improve people’s lives.
Our team brings together deep immunoscience and cutting-edge innovation across oncology, rare diseases, neurology, and vaccines, combining lab science with AI-powered discovery to deliver real-world impact.

🎯 About the Role

Are you ready to shape the future of medicine?
As a Global Safety Officer (GSO) in the Rare Diseases team, you will play a critical role in drug discovery and development by ensuring patient safety through expert pharmacovigilance (PV) and risk management practices.

You’ll collaborate with cross-functional global teams to evaluate safety data, lead risk assessments, and ensure compliance with international PV regulations — all while driving strategic decision-making that affects patients worldwide.

🧩 Main Responsibilities

🔹 Safety Expertise & Risk Management

Act as internal and external safety expert for assigned products.
Provide pharmacovigilance and risk management expertise across teams.
Maintain deep understanding of product attributes, benefit–risk profile, and emerging literature.
Ensure compliance with international safety regulations and PV guidelines.
Lead Safety Management Teams (SMTs) and Global PV Safety Analysis Teams (SATs).
Represent PV during meetings with key stakeholders, external partners, and health authorities.
Support due diligence and PV agreement activities.

🔹 Impact & Strategic Contributions

Continuously assess and monitor the product safety profile.
Contribute to and/or approve:
- Clinical development documents (protocols, SAPs, IBs, CSR, ISS, ISE, labeling, etc.).
- Responses to health authorities, IRBs, and external partners.
Manage product safety alerts and ensure effective internal/external communication of safety positions.
Strengthen credibility and visibility of the GSO function within Global PV (GPV).

🔹 Signal Detection & Assessment

Oversee signal detection and analysis across multiple data sources.
Collaborate with the Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology Group.
Implement proactive safety analysis strategies to refine product benefit–risk profiles.
Lead aggregate safety data reviews and safety surveillance activities.

🎓 Qualifications

Knowledge & Skills

Strong clinical judgment and decision-making.
Excellent written and verbal communication skills.
Ability to synthesize and critically analyze safety data from multiple sources.
Expertise in risk assessment and benefit–risk evaluation.
Proven leadership in cross-functional environments.
Strong interpersonal and teamwork skills.
Fluent in English (written and spoken).

Education & Experience

Degree: D.O., M.D., or equivalent.
Board Certification: Preferred (or board eligible).
Experience:
- Minimum 3 years of international pharmacovigilance or equivalent relevant industry experience (e.g., clinical development).
- Exceptional candidates with proven excellence in similar roles may be considered with less experience.

🌟 Why Choose Sanofi

Be part of a future-focused, science-driven global team.
Explore unlimited career growth through promotions, lateral moves, or international mobility.
Receive a comprehensive rewards package, including:
- High-quality healthcare & wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Competitive compensation and benefits aligned with your experience.

⚖️ Diversity & Inclusion

Sanofi is an Equal Opportunity and Affirmative Action Employer, committed to building a culturally diverse workforce.
We welcome all qualified applicants regardless of race, color, religion, gender, national origin, sexual orientation, age, disability, or veteran status.

🚀 Join Us

At Sanofi, we believe in Pursuing Progress and Discovering the Extraordinary.
Together, we’ll challenge conventions, push boundaries, and deliver smarter solutions that improve lives worldwide.

🔗 Learn more: sanofi.com

#GD-SA | #LI-SA | #LI-Onsite | #VHD

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Global Safety Officer, Rare Diseases

Job Description

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