Audit and Inspection Coordinator (H/F)

About the job As Audit and Inspection Coordinator VIE within our Pharmacovigilance (PV) Quality team, you’ll work with global teams to integrate quality standards and initiatives. Your routine activities will be PV audit preparations and follow up, health authority PV inspections support, audit and inspection findings trending and oversight of CAPA implementation, and the projects include tools / digital initiatives and process improvements. ​​Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. Ready to get started? 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 AIR (Audit and Inspection readiness) team activities for audits and inspections, i.e. support the management of pre-requests, participation in the back room, follow up of CAPAs, and other. - Contribute to deliver metrics for the Quality Forum, AIPG (Audit/inspection PV Governance) Meeting, PSPV (Patients Safety Pharmacovigilance) quarterly reports and monthly reports. - Support the management of PV Service Providers and Business Partners audits - Support in the preparation of country office audits and inspections, definition of root-cause analysis and Corrective & Preventive Actions (CAPA) follow-up. - Support country office to pull ICSR compliance data at time of audits and inspections and for routine monitoring. - Work with PV Compliance team to identify missing investigations and / or trends related to local ICSR Compliance. - Provide analysis of PV findings trends across regions for audits and inspections. - Provide support for the maintenance of the Pharmacovigilance System Master File (PSMF). - Lead and support AIR apprentice in the launch of the survey for the lessons learned from the PV inspections and support the preparation of the action plan based on the results. - Provide support for completion of survey for global process audits. - Engage in development and implementation of training materials related to process improvement initiatives. - Contribute in joint projects between Audit and inspection readiness team and PV compliance team. Why choose us? - Be part of a pioneering biopharma company where patient insights shape drug development. - Work at the forefront of AI-powered science that accelerates discovery and improves outcomes. - Collaborate beyond your expertise, sparking new ideas with diverse, multidisciplinary teams. - Help improve the lives of millions of people globally by making drug development quicker and more effective. - Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice. - Achieve genuine work-life balance in a supportive R&D environment. iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow. Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work. Pursue Progress. Discover Extraordinary. 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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

About you Experience: - Experience in Pharmacovigilance / Medical Affairs / Regulatory Affairs or Quality Assurance. - Experience in CAPA (Corrective and Preventive Actions) management. Soft and technical skills: - Good interpersonal communication and networking skills. - Able to work transversally and to network with key stakeholders. - Goal oriented. - Dependability, independent yet willing to incorporate feedback. - Organized and detail oriented, efficient at time management. - Effective problem-solving skills, quick learner, analytic thinker. - Understanding of Pharmacovigilance regulatory requirements. - Tech-savvy, knowledge of MS office (proficient use of Excel and PowerPoint). Education: - Pharmaceutical Degree or Master's Degree in Human Health Sciences. Languages: - Fluent in English - verbal and written. To facilitate the examination of your application by our English-speaking managers, thank you for applying in English.

La volonté de faire progresser la science nous unit. En France, nous sommes plus de 20 000 hommes et femmes passionnés. L’innovation est un parcours inattendu de défis. Alors, sans relâche, nous repoussons nos limites pour transformer la pratique de la médecine et améliorer la santé des patients avec nos médicaments et vaccins.