Requirements: English
Company: ProductLife Group
ProductLife Group is looking for a Case Specialist (Pharmacovigilance) to join our dynamic team to contribute to the ICSR Case Processing activities performed in the Hub: Specific activities and responsibilities: Responsible for the Quality control of vigilance cases Medical evaluation of reports Data entry of vigilance cases in ad hoc databases or in other formats agreed with the client Follow-up request of vigilance cases by phone/mail Pre-analysis of complex cases prior to data entry Medical evaluation of files on: Coding (according to applicable dictionary) Causal relationship between the effects and the intake of suspect products (according to applicable method) The expected/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 and applicable changes to set up ICSR/MLM filters Analysis of inclusion / exclusion of EV/MHRA cases To perform the QC for post-marketing cases To provide specialised and dedicated pharmacovigilance support to the team specifically with the review, assessment and querying of safety reports. To perform medical review of post marketing cases as assigned. Required education: Pharmacist or Life Science Degree Required experience : Min 2 years experience in PV case processing PV database experience- Safety Easy Knowledge of GCP/GVP Deep experience in PV principles, adverse event reporting, causality assessment Experience of communicating directly with clients Required Languages: French (Full professional) English (Full professional) Required technical skills: Microsoft Office Teamwork Attention to detail Flexibility Process Orientated Organization