About the job

As PV Literature Surveillance Expert within our Pharmacovigilance department, you'll support the oversight and management of our global literature surveillance process, working closely with vendors and technology teams to ensure comprehensive safety monitoring.

You'll play a key role in our Pharmacovigilance team, managing literature surveillance activities that support safety reporting, signal detection, and regulatory compliance. Working in a global environment, you'll coordinate between internal stakeholders and external vendors to ensure our literature monitoring meets the highest standards and regulatory requirements.

About Sanofi:

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main responsibilities:

• Support the Global Lead in overseeing and managing the PV literature surveillance process and resources across the organization
• Manage vendor activities for literature surveillance and screening, ensuring quality and compliance with regulatory requirements
• Oversee technology teams or vendors responsible for the literature screening platform, ensuring optimal performance and functionality
• Collaborate with Global Safety Operations and vendors to develop effective search strategies for comprehensive literature coverage
• Coordinate with stakeholders to meet literature needs for individual case safety reports, signal detection, periodic safety reports, and affiliate/partner requirements
• Serve as subject matter expert for literature surveillance during audits and inspections, effectively communicating processes and compliance measures
• Support both routine and ad-hoc literature surveillance activities, ensuring stakeholder needs are met efficiently

About you

• Education: Pharm.D. or bachelor's degree in health science or related field (e.g., pharmacy or nursing) preferred
• Experience: Background in international pharmacovigilance for marketed products and/or clinical development; previous experience surveilling and assessing literature for safety or medical purposes
• Technical skills: Knowledge of individual case safety reports, signal/risk management, and periodic safety reporting as related to literature surveillance; computer literacy with Windows-based programs; familiarity with literature screening platforms
• Regulatory knowledge: Working knowledge of worldwide pre- and post-marketing safety reporting regulations and requirements including ICH guidelines
• Collaboration skills: Ability to work effectively in a global, multi-entity, multi-cultural environment across time zones; strong teamwork and stakeholder management capabilities
• Problem-solving abilities: Capability to organize and multitask effectively, take initiative, and think strategically with continuous process improvement in mind
• Languages: Excellent English communication skills, both verbal and written

Why choose us?

• Contribute to patient safety on a global scale through comprehensive literature surveillance
• Work with cutting-edge technology platforms and innovative approaches to pharmacovigilance
• Collaborate with diverse, international teams and external partners across multiple time zones
• Develop your expertise in a critical area of drug safety and regulatory compliance
• Access continuous learning opportunities and professional development in pharmacovigilance

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!