ProductLife Group is looking for Case Specialist (Pharmacovigilance) to join and contribute to the activities of the hub.
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 perform QC for clinical/post-marketing cases
Key Contact for specific customers (with the support of an Activity Manager or the Line Manager)
To perform QC for clinical/post-marketing cases
Key Contact for specific customers (with the support of an Activity Manager or the Line Manager)
- Doctor in Pharmacy/ Pharmacist by training
- Minimum 3 years of experience in a similar position
- Previous experience working to deadlines
- Database experience
- Clinical and Post Marketing case processing experience
- Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
- Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
- 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