Global Safety Officer, I&I

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 – Immunology & Inflammation (I&I)

📍 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 leader driven by one purpose — to chase the miracles of science to improve people’s lives.
We combine deep immunoscience with AI-powered innovation across multiple therapeutic areas including oncology, rare diseases, neurology, and vaccines.
Here, you’ll collaborate across boundaries, explore your scientific curiosity, and turn breakthrough ideas into real-world medical impact.

🎯 About the Role

The Global Safety Officer (GSO), Immunology & Inflammation (I&I) plays a critical role in ensuring patient safety throughout the drug lifecycle.
You will serve as the medical safety expert responsible for signal detection, risk assessment, benefit–risk evaluation, and safety communication for assigned products.
This position requires strong leadership, cross-functional collaboration, and in-depth pharmacovigilance expertise to support Sanofi’s mission to deliver safe, effective, and innovative therapies.

🧩 Main Responsibilities

🔹 Safety Expertise & Risk Management

Provide pharmacovigilance (PV) and risk management expertise to internal and external stakeholders.
Serve as the safety expert for assigned products.
Maintain comprehensive knowledge of product attributes, the therapeutic environment, and recent scientific literature.
Ensure compliance with international PV regulations and guidelines.
Lead Safety Management Teams (SMTs) and Safety Analysis Teams (SATs).
Represent PV in discussions with project teams, external partners, key opinion leaders, and health authorities.
Provide strategic, proactive safety input into product development plans.
Support due diligence activities and pharmacovigilance agreements.

🔹 Impact & Strategic Leadership

Conduct ongoing assessment of the product’s safety status.
Review and contribute to critical clinical and regulatory documents such as:
- Clinical Development Plans
- Study Protocols & Statistical Analysis Plans (SAPs)
- Investigator Brochures (IBs)
- Study Reports and Integrated Summaries of Safety (ISS/ISE)
- Labeling and other safety documentation
Respond to queries from health authorities, IRBs, and external partners.
Manage product safety alerts and ensure effective communication of PV positions.
Establish credibility and visibility of the Global Patient Safety (GPE) function.

🔹 Signal Detection & Assessment

Oversee signal detection and analysis across multiple data sources.
Collaborate with the Center of Excellence for Signal Detection, Data Mining, and Safety Epidemiology teams.
Implement proactive strategies to refine the safety profile and enhance the benefit–risk assessment.
Lead aggregate data reviews and coordinate ongoing safety surveillance activities.

🔹 Risk Assessment & Benefit–Risk Management

Conduct risk assessments and develop risk management strategies.
Co-lead benefit–risk evaluations with clinical and regulatory functions.
Monitor the effectiveness of risk minimization measures.
Collaborate closely with the Center of Excellence for Risk Management and Safety Epidemiology.

🔹 Regulatory Submissions & Report Writing

Represent safety perspectives on cross-functional submission teams.
Ensure consistency and quality of safety sections in regulatory submission documents.
Draft and review responses to Health Authority inquiries.
Support Advisory Committee meeting preparations.
Author and review periodic safety reports, including:
- Risk Management Plans (RMPs)
- IND Annual Reports
- Annual Safety Reports (ASRs) / DSURs
- Periodic Safety Update Reports (PSURs)

🎓 Qualifications

Knowledge & Skills

Excellent clinical judgment and analytical thinking.
Strong ability to synthesize and interpret data from multiple sources.
Clear and effective communicator, both oral and written.
Skilled in preparing and documenting risk assessments.
Proven leadership and teamwork in cross-functional settings.
Ability to work under pressure and manage competing priorities.
Fluent in English (written and spoken).

Education & Experience

Medical Degree (M.D. or equivalent) required.
Board Certification/Eligibility preferred.
Minimum 3 years of experience in international pharmacovigilance or equivalent relevant industry experience (e.g., clinical development).
Candidates with proven excellence in similar prior roles may be considered with less experience.

🌟 Why Choose Sanofi

Work with a future-focused, science-driven global healthcare leader.
Access unlimited career growth opportunities across global networks.
Receive a competitive compensation and benefits package, including:
- High-quality healthcare & wellness programs
- At least 14 weeks of gender-neutral parental leave
- Recognition programs and performance-based rewards

⚖️ Diversity, Equity & Inclusion

Sanofi is an Equal Opportunity and Affirmative Action Employer, committed to building a culturally diverse and inclusive workforce.
All qualified applicants will receive equal consideration regardless of race, gender, nationality, age, disability, sexual orientation, or veteran status.

🚀 Join Us

At Sanofi, we believe in Pursuing Progress and Discovering the Extraordinary.
Join us in shaping the future of medicine — where your growth is as transformative as the science we create.

🔗 Learn more: www.sanofi.com

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

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Global Safety Officer, I&I

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