LUDIVINE DOUARIN, Benefit-Risk Expert, Sanofi

Ludivine is pharmacist by training with diploma in clinical development, statistics and quantitative epidemiology and a Master degree on real life evaluation of medicinal products, market access, and public health. She has more than 18 years of experience in different roles in Global Pharmacovigilance, starting in case management and safety analysis, than signal detection where she actively contributed to the development of the business process for quantitative signal detection and evaluation and dedicated tools, and risk management activities for a large number of marketed and investigational products across different therapeutic areas including rare diseases, diabetes and cardiovascular, oncology and multiple sclerosis.

Since 2018, she is a benefit-risk expert and leads the development of patient-centric benefit-risk assessments for drugs and vaccines in development from before phase 1 to pre-submission phases, and for marketed drugs and vaccines, in close collaboration with stakeholders from other functions (e.g., pharmacovigilance, pharmacoepidemiology, medical, regulatory, statistician, clinical development).