Requirements: English
Company: ProductLife Group
Region: france, fr ,
ProductLife Group is looking for a Case Specialist(Pharmacovigilance) to join our dynamic team to contribute to theICSR Case Processing activities performed in the Hub: Specificactivities and responsibilities: - Responsible for the Qualitycontrol of vigilance cases - Medical evaluation of reports - Dataentry of vigilance cases in ad hoc databases or in other formatsagreed with the client - Follow-up request of vigilance cases byphone/mail - Pre-analysis of complex cases prior to data entry -Medical evaluation of files on: - Coding (according to applicabledictionary) - Causal relationship between the effects and theintake of suspect products (according to applicable method) - Theexpected/listed or unlisted nature of the events/effects/incidents- The seriousness of the events/effects/incidents and the case -Identification of submission requirements for each case -Validation of certain documents produced by the Data Manager/Vigilance Associate / documentalist (phone call forms, etc) -Closing of vigilance files - Identification of requirements andapplicable changes to set up ICSR/MLM filters - Analysis ofinclusion / exclusion of EV/MHRA cases - To perform the QC forpost-marketing cases - To provide specialised and dedicatedpharmacovigilance support to the team specifically with the review,assessment and querying of safety reports. - To perform medicalreview of post marketing cases as assigned. Required education:Pharmacist or Life Science Degree Required experience : - Min 2years experience in PV case processing - PV database experience-Safety Easy - Knowledge of GCP/GVP - Deep experience in PVprinciples, adverse event reporting, causality assessment -Experience of communicating directly with clients RequiredLanguages: - French (Full professional) - English (Fullprofessional) Required technical skills: - Microsoft Office -Teamwork - Attention to detail - Flexibility - Process Orientated -Organization