Group 10

ProductLife Group is looking for a Case Specialist to join our dynamic team to contribute to the activities performed in the Hub:

Group 10

  • 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:
  1. Related to their activity
  2. Related to particular activities carried out in their Business unit for specific clients

Group 10
Education & Experience:

  • Doctor or pharmacist by training
  • 1-3 years of experience in a similar position
  • Knowledge of Pharmacovigilance would be an advantage

Group 10

  • Database experience preferred
  • Knowledge of current regulations
  • Process oriented
  • Rigorous and ability to work in a team
  • Use of Microsoft Office tools
  • Ability to multitask
  • Flexibility
  • Excellent communication skills in English for business continuity