Lyon, Auvergne-Rhône-Alpes, France
Pharmacist with over 5 years of experience conducting RWE (Real-World Evidence) and pharmacoepidemiological studies within leading pharmaceutical companies.I specialise in safety signal evaluation, managing complex projects, and collaborating with interdisciplinary teams to transform clinical and epidemiological data into strategic insights. My skills include managing multi-company consortium, critically reviewing scientific literature, and analyzing medico-administrative data to meet the needs of health authorities and internal stakeholders. Objective: To contribute to patient safety and treatment optimization by leveraging real-world data, clinical trial data, and rigorous methodologies to deliver actionable insights and evidence-based strategies.
Supervised a team of 3.5 FTEs, managing workload distribution, operational support, and day-to-day coordination. Monitored pharmacovigilance compliance through weekly/monthly ICSR reviews and oversight of literature and bibliographic surveillance activities. Led cross-functional collaboration with medical, regulatory, and quality teams, and coordinated data reconciliations with affiliates and distributors. Managed external vendors by monitoring KPIs, resources, and budget, while contributing to transversal initiatives and safety committees.
Conducted epidemiological evaluations of safety signals, including scientific literature reviews and preparing RMP and PSUR reports. Led a multi-company consortium: organized meetings, resolved issues, and ensured project follow-ups. Collaborated cross-functionally with pharmacovigilance, medical, and regulatory teams.
Designed and conducted pharmacoepidemiological and RWE studies. Supervised data scientists in the delivery of complex projects. Produced bibliographic reviews, synthesis documents, and presentations for PE/RWE projects.
Coordinated pharmacoepidemiological studies for the RWE unit. Drafted and validated protocols, study reports, and statistical analysis plans. Provided scientific expertise and RWE support to medical and market access teams.
Managed routine pharmacovigilance and quality assurance activities within an international pharmaceutical environment. Contributed to audits of the promotional charter, participated in legal case management, and drafted tolerance sections for transparency commission files. Gained in-depth knowledge of the vaccine environment, pharmacovigilance operations, and quality assurance processes. Collaborated with medical affairs and market access teams, using MAARS/Argus, TRACKWISE, and other MSD tools in a cross-functional, English-speaking context.