Case specialist- pharmacovigilance (clinical trial)

Product Life 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. Safety Easy/ 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