Job Title:
Global Literature Surveillance Strategy and Innovation Lead
📍 Location:
Cambridge, Massachusetts, USA
Morristown, New Jersey, USA
💼 Employment Type:
Regular / Full-time
💰 Salary Range:
USD 172,500.00 – 249,166.66
About the Job
Bring your curiosity to a team where deep immunoscience meets cutting-edge innovation. Across oncology, rare diseases, neurology, and vaccines, Sanofi combines lab science with AI-powered discovery, transforming breakthrough ideas into real-world impact.
This role sits within Patient Safety & Pharmacovigilance (PSPV) — a global team committed to ensuring the safety of Sanofi’s therapies and optimizing benefit–risk profiles to serve patients better.
The Global Literature Surveillance Team plays a key role in monitoring medical literature for safety information relevant to Sanofi’s products, supporting global pharmacovigilance compliance, and contributing to activities like ICSR identification, signal management, and PBRER/DSUR reporting.
🎯 Main Responsibilities
Lead the Global Literature Surveillance strategy, overseeing both routine and ad-hoc processes.
Manage internal and external literature teams, ensuring efficiency, accuracy, and compliance.
Oversee vendor operations — including screening, translations, article procurement, and quality assurance.
Act as Business Owner for the Pharmacovigilance Literature Database.
Stay current on AI and machine learning innovations and their regulatory implications in literature screening.
Collaborate with the PSPV Digital Team to implement and assess new AI-driven tools to enhance process efficiency.
Develop, implement, and maintain business processes, SOPs, and standards for literature surveillance.
Coordinate stakeholder needs across ICSR, signal management, risk management, and periodic reporting.
Support affiliate and partner literature requirements globally.
Define and evolve PSPV’s literature vision in alignment with Sanofi’s expanding product portfolio.
Participate in audits and inspections as needed.
Demonstrate strong knowledge of literature alert creation for databases like Embase and Medline.
🎓 Required Education & Experience
Pharm.D. or Bachelor’s degree in a health science-related field (Pharmacy or Nursing preferred).
Minimum 10 years of experience in Pharmacovigilance, covering both marketed and development products.
Experience in regulated environments (GVP compliance).
Proven leadership in managing teams and large-scale projects.
Experience with ICSRs, Periodic Safety Reports, and Clinical Overviews (Type II variations).
Strong understanding of literature surveillance systems and pharma safety reporting.
Proficient with Windows-based applications and relevant PV systems.
🧠 Key Skills & Competencies
Technical Skills:
Deep knowledge of pharmacovigilance processes, signal management, and regulatory reporting.
Understanding of AI/ML applications in literature screening.
Expertise in global literature repositories (Embase, Medline).
Soft Skills:
Excellent team leadership and cross-functional collaboration abilities.
Strong communication and stakeholder management skills.
High adaptability and ability to manage multiple global priorities.
Demonstrated success working across time zones, cultures, and entities.
Committed to accuracy, quality, and regulatory compliance.
Languages:
Fluent in English
🌍 Why Choose Sanofi
Be part of a future-focused, innovative team transforming patient safety through science and technology.
Access endless global career opportunities — from promotions to lateral moves.
Receive a comprehensive rewards package recognizing your contributions.
Enjoy world-class wellbeing programs, healthcare benefits, and 14 weeks of gender-neutral parental leave.
🌈 Equal Opportunity Statement
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers, committed to diversity, equity, and inclusion.
All qualified applicants will receive consideration without regard to race, color, religion, national origin, sex, age, disability, veteran status, or any other protected characteristic.
🏢 Job Category:
Pharmacovigilance / Drug Safety / Literature Surveillance & AI Innovation
📍 Country:
United States (USA)
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science — where your growth is as transformative as the lives you’ll impact.
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