Instagram
youtube
Facebook

Global Safety Officer, Rare Diseases

3+ years
USD 172,500.00 - 287,500.00
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

📍 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.