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Innovation
Consulting

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

Group 10
Responsibilities:

  • 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)
  • To perform medical review of post marketing cases as assigned.
  • To be the Operations lead for assigned post marketing clients.
  • 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 10
Education and Experience

  • Doctor or pharmacist by training
  • 2-3 years PV post marketing case processing experience.
  • Knowledge of GCP/GVP especially module VI
  • Knowledge of ICH E2B guidelines
  • Experience of medical review of post marketing cases
  • Experience of communicating directly with clients
  • Prior experience in a similar position is preferred

Group 10
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

Senior Case Specialist 807

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