ProductLife Group is looking for a Case Specialist to join our dynamic team to contribute to the 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 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.
To be the Operations lead for assigned post marketing clients.
To coordinate the case management activities and ensure the compliance of case processing timelines and target KPI

Required education:

Pharmacist