Job Description

Group 10

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

Group 10 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

    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

    • Group 11 Education & Experience:

    Doctor in Pharmacy/ pharmacist by training

    1-3 years of experience in a similar position

    Knowledge of Pharmacovigilance would be an advantage

    Group 13 Skills:

    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

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