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About the Role
ProductLife Group is looking for Case Specialist (Pharmacovigilance) to join and contribute to the activities of the hub.
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 / docum...
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