Requirements: English
Company: ProductLife Group
Region: france, france ,
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