Pharmacovigilance Officer (Case Specialist)

ProductLife Group; Paris; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A dynamic healthcare company in Paris is seeking a Pharmacovigilance Officer (Case Specialist) to join their team. The role involves quality control of vigilance cases, medical evaluation of reports, and coordination of case management activities. Candidates should have a pharmacist degree and at least 2 years of experience in pharmacovigilance case processing. Proficiency in French and English is required, along with experience in using PV databases like Argus or SafetyEasy. This position offers an opportunity to contribute to improving patient safety through effective case management.

Qualifications

• Minimum 2 years of experience in pharmacovigilance case processing.
• Experience with PV databases like Argus or SafetyEasy.
• Knowledge of GCP/GVP guidelines.

Responsabilités

• Conduct quality control of vigilance cases.
• Perform medical evaluations of safety reports.
• Coordinate case management activities.

Connaissances

Pharmacovigilance case processing

Client communication

Attention to detail

Teamwork

Formation

Pharmacist

Outils

Microsoft Office

Argus

SafetyEasy

Description du poste

ProductLife Group is looking for a Pharmacovigilance Officer (Case Specialist)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 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.
• To be the Operations lead for assigned post marketing clients.
• To coordinate the case management activities and ensure the compliance of case processing timelines and target KPI

Required education:

Pharmacist

Required experience :

• 2 years experience in PV case processing
• PV database experience- Argus/ SafetyEasy
• Knowledge of GCP/GVP
• 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