Drug Safety Coordinator

Pharmacovigilance Lead- Office Based-South Korea-ICON Strategic Solutions

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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• PV system management
  • SOP/Work Instruction 등 개발
  • Safety Database 관리
  • PV Audit·Inspection 대응 및 CAPA 이행

• Safety management for post market product
  • Adverse Event 관리(수집/검토/DB입력/평가/보고)
  • Literature Searching
  • Signal Detection 및 Evaluation
  • Risk Management Plan 작성 및 이행
  • Safety Reports 작성(PV Plan, PSUR/PBRER, RMP등)
  • Safety Profile 및 Company Core Safety Information 관리
  • Reconciliation

• Safety management for clinical trial
  • Protocol 및 CSR 검토
  • SAE 관리(수집/ 검토/DB입력/평가/보고)