Virginie Mommer

Establishment and maintenance of the local Pharmacovigilance (PV) system in Belgium and Luxembourg. Responsible for all related PV activities at local level including but not limited to case management, local regulatory intelligence, local literature screening, signal detection, risk management and risk mitigation activities, market research programs for PV aspects, PV training, etc. Acting as Local Contact Person for PV.

Responsible for implementation and performance of day-to-day Insuvia's pharmacovigilance operations in Belgium and Luxembourg. Acting as Local Person for PV (LPPV) or Deputy LPPV on behalf of assigned Insuvia's contractual partners, including serving as the main / deputy PV contact person for NCAs, assurance of Regulatory Intelligence, handling of NCAs requests, literature screening and monitoring of websites, local processing of ICSRs, implementation and/or oversight of local risk minimization measures, delivery of pharmacovigilance training to concerned stakeholders and other applicable local PV tasks or responsibilities. Assuring required PV support for assigned Insuvia contractual partners.

Establishment and maintenance of PV system in the company. Oversight, planning and performance of pharmacovigilance activities: ICSRs management (including collection, database entry, MedDRA Coding, quality control and expedited reporting), Edition, review and submission of safety aggregate reports (PSURs, DSURs), Edition and review of RMPs, Implementation and follow-up of risk minimization activities, Edition and maintenance of the PSMF, Signal detection and management, Edition and review of SDEAs, Literature screening, Medical information, responsible of the Quality Management System, audit performance and participation etc.