Pharmacovigilance Associate

2 weeks ago

Taguig, National Capital Region, Philippines Celltrion Inc Full time ₱300,000 - ₱450,000 per year

Key Responsibilities

  • Receive, record, and process Individual Case Safety Reports (ICSRs) from clinical trials, healthcare professionals, patients, and literature sources.
  • Ensure timely entry of adverse event data into the safety database in compliance with regulatory timelines.
  • Assist in coding adverse events using MedDRA terminology and verifying case accuracy.
  • Support preparation of expedited safety reports and aggregate reports (e.g., DSURs, PSURs).
  • Help maintain safety files and documentation in accordance with internal SOPs and regulatory requirements.
  • Monitor literature sources for potential adverse event reporting.
  • Provide administrative and operational support to the PV team, including safety data reconciliation with partners and CROs.
  • Assist during audits, inspections, and regulatory queries by preparing necessary safety documentation.
  • Participate in PV-related training and continuous improvement activities.

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