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Case Specialist 196,197,198

Case Specialist 196,197,198

ProductLife GroupPhilippines
22 days ago
Job description

ProductLife Group is looking for a 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

  • Pharmacist or Life Sciences degree with more than 3 years experience in PV

    • Group 10 Profile :

  • Previous experience working to deadlines.
  • Client communications
  • SafetyEasy database experience
  • Minimum 3 years experience working for service providers performing QC of cases
  • Microsoft package
  • Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
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    Specialist • Philippines