Global Medication Safety Expert

14 hours ago

Cagayan de Oro, Northern Mindanao, Philippines beBeePharmacovigilance Full time ₱3,600,000 - ₱5,400,000
Case Specialist Job Description

A Case Specialist is responsible for performing a variety of tasks related to data entry, quality control, and medical review.

Key Responsibilities:

  • Data entry of vigilance cases in relevant databases according to conventions and regulatory requirements.
  • Quality control of vigilance cases and associated documents to ensure accuracy and compliance.
  • Medical review of vigilance cases according to conventions and regulatory requirements, including analysis of ICSRs from competent authorities.
  • Follow-up requests by phone or mail, as well as pre-analysis of complex cases before data entry.
  • Identification of submission requirements for safety cases and reconciliation of discrepancies with partners, medical information, and quality complaints.
  • Participation in operational project implementation, including key contact responsibilities and collaboration with team leaders.
  • Review and analysis of post-marketing cases, including medical review and operations lead responsibilities for assigned clients.

Requirements:

  • Pharmacist or Life Sciences degree with more than 3 years experience in PV (pharmacovigilance).
  • Previous experience working to deadlines and meeting client expectations.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.
  • Understanding of GVP, GCP, FDA, and regulatory requirements.
  • Minimum 3 years experience in QC of cases for service providers, with strong communication and analytical skills.

Benefits:

  • Opportunity to work with a dynamic team in a fast-paced environment.
  • Chance to develop skills in data entry, quality control, and medical review.
  • Collaborative work environment with opportunities for growth and development.

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