Dr. Delphine Saragoussi is Head of Pharmacoepidemiology Vaccines within Patient Safety and Pharmacovigilance at Sanofi, in the greater Paris metropolitan area. She is a physician specialized in public health and social medicine and offers more than 20 years of applied experience in epidemiology and pharmacoepidemiology. Trained in medicine at the Paris V Descartes University, Dr. Saragoussi also earned a Master’s degree in methodology and statistics in biomedical research from Paris XI University. Dr. Saragoussi has a deep understanding of strategic real-world evidence (RWE) needs throughout the development and lifecycle of drugs and vaccines and has developed and implemented several peri- and post-approval RWE plans to support continuous benefit-risk assessment and value demonstration of various medicinal products. Her research methods’ expertise covers the collection of primary data and use of electronic databases (European and US claims and electronic medical records databases) and focuses on post-authorization safety studies to meet European and US regulatory and pharmacovigilance needs. Her experience also includes the design of epidemiological surveillance studies, vaccine impact studies, burden of illness evaluations, treatment patterns descriptions, patient-reported outcome validation, and real-world effectiveness studies. She previously served as Executive Director, Epidemiology and Scientific Affairs, at Evidera/PPD, part of Thermo Fisher Scientific, where she focused on safety studies and RWE generation in the vaccine and rare diseases spaces. Before that, she was Global Therapy Area Lead in the Real-World Evidence and Epidemiology department at Lundbeck where she led psychiatry and neurology RWE research. She has also worked in academic research units, in semi-private health insurance companies and at the French Drug Agency. Dr. Saragoussi has been teaching pharmacoepidemiology at the Paris V Descartes University and regularly publishes her works in peer-reviewed journals.