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

  • 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

Education & Experience

  • Doctor or pharmacist by training
  • Prior experience in a similar position is preferred
  • 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

07 April, 2022

Spontaneous Application

Case Specialist 509

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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