About the job

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

Responsabilities

  • 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

Education & Experience

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

Profile

  • 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 French and in English for business continuity

Publish Date

24 March, 2022

Spontaneous Application

Case Specialist 501

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

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