Regulatory Case Specialist

13 hours ago

Pasay, National Capital Region, Philippines beBeeRegulatory Full time ₱4,500,000 - ₱7,000,000
Job Title: Regulatory Case SpecialistThe Regulatory Case Specialist will be responsible for ensuring the accurate and timely processing of case data.
Responsibilities:
  • 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 others documents directly related to their activity.
  • Participation in the implementation/maintenance/improvement of processes.

Requirements:
  • 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.

Benefits:The successful candidate will have the opportunity to work on a wide range of projects and contribute to the growth and success of our organization. They will also have access to ongoing training and development opportunities to help them advance their career.

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