Rennes
Coordination and supervision of Clinical Operations in Europe including Project Management, Monitoring, Regulatory Affairs (EU submissions to Competent Authorities), Pharmacovigilance (SAE/SUSAR via EudraVigilance) and Pharmaceutical Sciences (Investigational medicinal products management according to Annex 13 of GMP).
Management of planning, human resource, budgets for Phase I to Phase IV clinical trials in Europe.
Scientific advisor in clinical research / early phase development program, feasibility and follow-up of phase I studies (Early development & clinical pharmacology, Psychopharmacology, Cardiac Safety, Translational Medicine, Drug Drug Interactions, bioequivalence, regulatory and pharmaceutical aspects)
