Case Specialist- Pharmacovigilance; Clinical Trial

Position: 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