Expert Case Reviewer

2 days ago

Taguig, National Capital Region, Philippines beBeeSpecialist Full time ₱4,000,000 - ₱5,000,000
Case Specialist

We are seeking a highly skilled Case Specialist to join our team. The ideal candidate will possess excellent analytical and communication skills, with the ability to work independently and as part of a team.

The Case Specialist will be responsible for:

  • Data entry of vigilance cases in relevant databases according to relevant conventions.
  • Quality control of vigilance cases and other documents associated with safety reports.
  • Medical review of vigilance cases according to relevant conventions and regulatory requirements.
  • Follow-up requests of vigilance cases by phone/mail.
  • Pre-analysis of complex cases before data entry.
  • Identification of submission requirements for safety cases.
  • 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 other documents directly related to their activity.
  • Participation in the implementation/maintenance/improvement of processes.

The successful candidate will have:

  • Pharmacist or Life Sciences degree with more than 3 years experience in PV.
  • Previous experience working to deadlines.
  • Client communications.
  • Minimum 3 years experience working for service providers performing QC of cases.
  • 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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