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 Medical information in support of the medical information division Answering phone calls that generate safety notifications Review of medical information questions and quality complaints in order to identify safety information Key Contact for specific customers (with the support of an Activity Manager or the Line Manager) Writing/setting up quality documents in place:
    • Related to their activity
Related to particular activities carried out in their Business unit for specific clients

Required Education

Pharmacist or dentist or Nurse

Required Languages

English French

Required Technical Skills

PV database experience desirable

Additional Experience/Skills

  • Experience of medical review of post marketing cases
  • Knowledge of GCP/GVP
  • Experience of communicating directly with clients

Publish Date

21 August, 2023

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Case Specialist 960

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