ProductLife Group is looking for a Case Specialist to join our dynamic team to contribute to the 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:
  1. Coding (according to applicable dictionary)
  2. Causal relationship between the effects and the intake of suspect products (according to applicable method)
  3. The expected/listed or unlisted nature of the events/effects/incidents
  4. 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 :

  • 1-2 years experience in PV case processing
  • PV database experience
  • Knowledge of GCP/GVP
  • Experience of communicating directly with clients

Required Languages:

  • English
  • French (Plus to have)

Required technical skills:

  • Microsoft Office
  • Teamwork
  • Attention to detail
  • Flexibility
  • Process Orientated
  • Organisation

Case Specialist 198

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