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