ProductLife Group is looking for a Case Specialist to join our dynamic team to contribute to the activities performed in 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 / 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
Education & Experience:
- Doctor or pharmacist by training
- 1-3 years of experience in a similar position
- Knowledge of Pharmacovigilance would be an advantage
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 for business continuity
