Case Specialist- Pharmacovigilance
ProductLife Group is looking for a Case Specialist (Pharmacovigilance) to join our dynamic team to contribute to the activities performed in the Hub: Role: - 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 - Medical information in support of the medical information division - Related to particular activities carried out in their Business unit for specific clients Education & Experience - Doctor or pharmacist by training - Minimum 4 years experience working for service providers performing QC of case - Minimum 3 years of experience in processing Clinical Trial cases. - SafetyEasy/ Argus database experience Profile - Database experience preferred - Knowledge of current regulations - Process oriented - Rigorous and ability to work in a team - Use of Microsoft Office tools - Ability to multitask - Flexibility - Excellent communication skills in English and French for business continuity .