Vigilance Operations Lead

2 weeks ago


Marikina City, National Capital Region, Philippines beBeeCase Full time ₱2,500,000 - ₱3,500,000

We are seeking a highly skilled Case Specialist to join our team. This individual will be responsible for performing medical review of post marketing cases and leading operations for assigned clients.

Key Responsibilities:
  • Data entry of vigilance cases in relevant databases
  • Quality control of vigilance cases and associated documents
  • Medical review of vigilance cases according to 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)
Requirements:
  • Pharmacist or Life Sciences degree with more than 3 years experience in PV
  • Previous experience working to deadlines
  • Client communications
  • Strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety
What We Offer:
  • Opportunity to work on challenging projects
  • Collaborative and dynamic work environment

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