🧾 Job Title: Global Safety Officer – Rare Diseases
📍 Locations: Morristown, New Jersey | Cambridge, Massachusetts, USA
💰 Salary Range: USD 172,500 – 287,500
🏢 About Sanofi
Sanofi is a global biopharmaceutical leader dedicated to chasing the miracles of science to improve people’s lives.
Our work spans rare diseases, oncology, immunology, neurology, and vaccines, driven by cutting-edge AI-powered discovery and collaborative innovation.
Join a team that transforms scientific curiosity into real-world impact and offers endless opportunities to deepen your expertise or advance your leadership journey.
🎯 Position Overview
As a Global Safety Officer (GSO) – Rare Diseases, you will serve as a medical safety expert responsible for assessing and managing the benefit–risk profile of rare disease products across all stages of development and commercialization.
You’ll play a vital role within the Global Pharmacovigilance (GPV) organization, ensuring patient safety through scientific excellence, regulatory compliance, and proactive signal detection.
⚙️ Main Responsibilities
🔹 Pharmacovigilance & Safety Leadership
Act as the internal and external safety expert for assigned rare disease products.
Provide pharmacovigilance (PV) and risk management expertise to internal stakeholders, external partners, and regulatory authorities.
Lead Safety Management Teams (SMTs) and Safety Analysis Teams (SATs) to coordinate global safety activities.
Maintain a comprehensive understanding of product science, therapeutic context, and emerging safety data.
Support due diligence activities and the development of PV agreements with partners.
Represent the GPV function in cross-functional and external meetings, effectively communicating Sanofi’s safety position.
🔹 Safety Evaluation & Risk Assessment
Continuously assess the safety status and benefit–risk balance of assigned products.
Review and contribute to clinical development documents, including:
Clinical Development Plans (CDPs)
Statistical Analysis Plans (SAPs)
Study Protocols and Reports
Investigator Brochures (IBs)
Integrated Summaries of Safety
Labeling and risk minimization measures
Respond to regulatory inquiries and ethics committee questions regarding product safety.
Manage safety alerts and ensure timely escalation and documentation.
🔹 Signal Detection & Data Analysis
Oversee signal detection and evaluation across multiple data sources.
Collaborate with the Center of Excellence for Signal Detection, Data Mining, and Safety Epidemiology teams.
Implement proactive safety analysis strategies to refine the product’s safety profile.
Lead reviews of aggregate safety data and coordinate safety surveillance activities globally.
🧠 Qualifications
Education
M.D., D.O., or equivalent medical degree required.
Board certification or eligibility preferred.
Experience
Minimum 3 years of international pharmacovigilance experience, or equivalent in clinical development or related industry roles.
Candidates with exceptional performance in similar roles may be considered with less experience.
Strong understanding of drug safety regulations, benefit–risk assessment, and signal management.
Knowledge & Skills
Excellent clinical judgment and ability to synthesize data from multiple sources.
Strong oral and written communication skills for complex scientific discussions.
Capable of developing sound risk assessments and contributing to regulatory decision-making.
Demonstrates leadership in cross-functional environments and manages competing priorities effectively.
Strong teamwork, interpersonal, and negotiation skills.
Fluent in English (written and spoken).
💡 Soft Skills
Self-driven, adaptable, and able to work under pressure.
Excellent analytical and problem-solving mindset.
Commitment to continuous learning and staying updated on product science and evolving PV regulations.
Collaborative, inclusive, and culturally aware in global team settings.
🌍 Why Work With Us
Shape the future of rare disease safety with a global leader in patient-centric healthcare.
Access career development opportunities — from promotions to cross-functional and international roles.
Enjoy a comprehensive rewards package that includes:
Competitive pay and bonus eligibility
Health and wellness benefits
Preventive care and wellbeing programs
At least 14 weeks of gender-neutral parental leave
Be part of a supportive, diverse, and innovation-focused culture that values your growth and wellbeing.
⚖️ Equal Opportunity Commitment
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action Employers, committed to fostering a culturally diverse and inclusive workforce.
All qualified applicants will receive consideration regardless of race, color, religion, gender, sexual orientation, age, nationality, disability, or any legally protected characteristic.
📌 Job Category
Pharmacovigilance / Drug Safety / Medical Affairs (Rare Diseases Division)
🚀 Join Us
Step into a new era of medical innovation with Sanofi.
Together, we’ll Pursue Progress and Discover Extraordinary — improving lives, protecting patients, and redefining what’s possible in rare disease care.
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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