Case specialist (chargé de vigilance)

ProductLife Group is looking for a Case Specialist (Pharmacovigilance) to join our dynamic team to contribute to the ICSR Case Processing 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 perform the QC for post-marketing 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.


Required education:

Pharmacist or Life Science Degree


Required experience :

* Min 2 years experience in PV case processing
* PV database experience- Safety Easy
* Knowledge of GCP/GVP
* Deep experience in PV principles, adverse event reporting, causality assessment
* Experience of communicating directly with clients


Required Languages:

* French (Full professional)
* English (Full professional)


Required technical skills:

* Microsoft Office
* Teamwork
* Attention to detail
* Flexibility
* Process Orientated
* Organization