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:

Group 10

  • Data entry of vigilance cases in the relevant databases according to relevant conventions
  • Quality control of vigilance cases and other documents associated to safety reports
  • Medical review of vigilance cases according to relevant conventions and regulatory requirements
  • Follow-up request of vigilance cases by phone/mail
  • Pre-analysis of complex cases before data entry
  • Identification  of  submission  requirements  for  safety cases
  • Identification  of  requirements  in  terms  of  preparation  of ICSR/MLM filters
  • Review and analysis of ICSRs downloaded from competent authorities databases
  • Performing reconciliations (partners, medical information, quality complaints)
  • Participation in the operational implementation of new projects
  • Key contact for projects (with support of the team leader/Activity manager/Project manager)
  • Drafting/updating  of  technical  agreements /safety  management  plan /client  template
  • Drafting/updating of SOPs/WPDs/Trainings others documents directly related to their activity
  • Participation in the implementation/maintenance/improvement of processes

Group 12
Education & Experience

  • Doctor or pharmacist by training
  • Prior experience in a similar position is preferred
  • Knowledge of Pharmacovigilance would be an advantage

Group 13

  • 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

Case Specialist 509