Vigilance Specialist/Medical Writer 314

ProductLife Group is looking for a Vigilance Specialist/ Medical Writer to join our dynamic team to contribute to the activities performed in the Hub:ResponsibilitiesActing as LRPPV in France and as single point of contact to French health authoritiesActing as a backup for local PV in FRHandling signal detection, Off label use reports and aggregate reports (DSUR, PSUR, RMP, ACP etc)Writing PSMF and SDEAConducting regulatory intelligence activitiesCapability to handle deputy and EU QPPV role (in future)Being involved in audits and health authority inspections on behalf of PLG clientsEducation & ExperienceMinimum 4 years experience in PV operational activitiesExperience in preparation of signal and aggregate reports (PSUR, DSUR etc.)BPPV/GVPKnowledge of case management at leastSkillsDatabase experience preferredKnowledge of current regulationsProcess orientedRigorous and ability to work in a teamUse of Microsoft Office toolsAbility to multitaskFlexibilityExcellent communication skills in French and in English for business continuity #J-18808-Ljbffr