Société : EUMEDICA S.A.Member of the Medical Affairs department, you will work with both our pharmacovigilance (4/5) and medical teams (1/5). As Pharmacovigilance Officer, you will be responsible for managing the PV cases on our products (from data collection to reporting). As Compliance Coordinator, you will manage and supervise the compliance of promotional activities in several European countries (no travel required). You report directly to the Pharmacovigilance Manager / EU - QPPV. Your responsibilities are : Being responsible for day-to-day processing of incoming adverse event reports in compliance with the internal SOPs/WINs and GVPs Where applicable, ICSR reporting to regulatory authorities and to partners within defined timeframe per local legislations and PV agreements Performing the expectedness assessment as per local reference document and CCDS Doing the medical assessment and writing of case narrative. According to the priority in the department, you might be participating in other medical affairs/pharmacovigilance related activities. Implement/Maintain and manage the quality system related to the compliance of promotional activities. Monitor the promotional activities (validate the promotional materials, ensure the compliance rules are followed by the sales team, report KPIs, ?). Train the sales teams. - Master?s degree in a health-related or scientific discipline (medical/biomedical sciences, pharmaceutical sciences,?) - Experience in Drug Safety / Pharmacovigilance role is an asset - Work precisely as per procedures, rules and regulations (an experience in writing/reviewing SOP is an asset) - Good organizational & administrative skills - Structured, rigorous, attached to details and deadlines - Able to work autonomously and as a member of a cross-functional team - Must be able/motivated to meet the reporting deadlines - Curious and enthusiastic - Fluent in French, English (spoken and written). Dutch and German are assets - At ease with IT tools: Ms Office We offer: - A full time long term contract - A salary package matching your competence -... Originele vacature is te vinden op StepStone.be ? Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
