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

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

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

27 February, 2023

Spontaneous Application

Senior Case Specialist 807

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.

Apply