Global Safety Officer – Immunology & Inflammation (I&I)
Locations: Cambridge, Massachusetts | Morristown, New Jersey
Employment Type: Full-Time | Permanent
Function: Global Pharmacovigilance / Drug Safety
Experience Level: Senior / Leadership
Experience Required: Minimum 3+ years in Global Pharmacovigilance
Salary Range: USD 178,500 – 297,500 (commensurate with experience)
Job Overview
Sanofi is seeking a highly experienced Global Safety Officer – Immunology & Inflammation (I&I) to join its global Research & Development organization. This critical leadership role is responsible for providing strategic pharmacovigilance oversight, benefit–risk assessment, and safety governance across complex global development and marketed products.
The role operates at the intersection of clinical science, regulatory strategy, and AI-powered safety analytics, contributing directly to Sanofi’s mission of delivering innovative therapies that transform patient outcomes worldwide.
About Sanofi
Sanofi is a global, R&D-driven, AI-powered biopharmaceutical company dedicated to improving lives through breakthrough medicines and vaccines. With deep expertise in immunoscience and a strong innovation pipeline across oncology, rare diseases, neurology, vaccines, and inflammatory disorders, Sanofi continues to push the boundaries of modern healthcare.
Key Responsibilities
Global Pharmacovigilance Leadership
Act as the global pharmacovigilance and risk management expert for assigned products
Maintain in-depth knowledge of product profiles, evolving safety data, and scientific literature
Ensure ongoing compliance with international safety regulations and pharmacovigilance guidelines
Safety Governance & Strategic Input
Lead cross-functional Safety Management Teams (SMTs)
Represent pharmacovigilance positions in internal governance bodies, including Safety Management Committees and Benefit–Risk Assessment Committees
Provide proactive safety input into clinical development and lifecycle management strategies
Support due diligence activities and pharmacovigilance agreements
Signal Detection & Safety Surveillance
Lead signal detection, validation, and assessment activities
Collaborate with Centers of Excellence for Signal Detection, Data Mining, and Safety Epidemiology
Define and implement proactive safety analysis strategies to refine product safety profiles
Oversee aggregate safety data review and safety surveillance activities
Risk Management & Benefit–Risk Assessment
Conduct proactive risk assessments and co-lead benefit–risk evaluations
Develop, implement, and monitor Risk Management Plans (RMPs)
Collaborate with epidemiology and benefit–risk teams to ensure robust risk mitigation strategies
Regulatory & Submission Activities
Represent the safety function in global regulatory submission teams
Ensure consistency, quality, and accuracy of safety sections in submission documents
Prepare responses to health authority queries and support advisory committee engagements
Safety Reporting & Documentation
Lead or contribute to the preparation, review, and validation of periodic safety reports, including:
Risk Management Plan (RMP) updates
IND Annual Reports
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs)
Serve as the medical safety expert for assigned products and projects
Required Qualifications
Education
Doctor of Medicine (MD) degree
Board-certified or board-eligible candidates preferred
Experience
Minimum 3+ years of experience in international pharmacovigilance
Prior experience in clinical development, drug safety, or related regulated environments considered
Exceptional candidates with demonstrated excellence in similar roles may be considered even with slightly less direct PV experience
Core Competencies
Strong clinical judgment and medical decision-making skills
Ability to synthesize and critically analyze data from multiple sources
Excellent written and verbal communication of complex safety concepts
Proven leadership within cross-functional and global team environments
Ability to work effectively under pressure in a fast-paced, regulated setting
Fluency in English (spoken and written)
Why Join Sanofi
Be part of a global organization driving innovation in immunoscience and AI-powered drug development
Work in a high-impact role influencing patient safety on a global scale
Access extensive career development, leadership growth, and international mobility opportunities
Benefit from a comprehensive rewards and benefits package, including healthcare, wellness programs, and gender-neutral parental leave
Equal Opportunity Statement
Sanofi and its affiliates are equal opportunity and affirmative action employers. Employment decisions are based on qualifications, merit, and business needs, without discrimination on any legally protected basis.
Apply now on thepharmadaily.com to join Sanofi’s global safety leadership team and play a pivotal role in advancing patient safety and benefit–risk excellence worldwide.
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