Case Specialist 345-348
004-placeholder Tunisia - Onsite - Life Cycle - Safety and Vigilance - 003-clock Permanent contract
Group 10
ProductLife Group is looking for a Case Specialist to join our dynamic team to contribute to the activities performed in the Hub:
Group 10 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
Medical information in support of the medical information division
Answering phone calls that generate safety notifications
Review of medical information questions and quality complaints in order to identify safety information
Key Contact for specific customers (with the support of an Activity Manager or the Line Manager)
Writing/setting up quality documents in place:
- Related to their activity
- Related to particular activities carried out in their Business unit for specific clients
Group 11 Education & Experience:
Doctor in Pharmacy/ pharmacist by training
1-3 years of experience in a similar position
Knowledge of Pharmacovigilance would be an advantage
Group 13 Skills:
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 French and in English for business continuity
Case Specialist 345-348
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