Drug Safety Coordinator

About the role 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. . 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) Safety Data Monitoring Pharmacovigilance training Training Plan 수립 및 Training Material작성 Training실시(신규입사자, 전사직원, 해외법인/파트너사, 주요 유관부서 등) PV agreement 관리 Local/Global Partners와 Safety Data Exchange Agreement(SDEA) 체결 Local/Global Partners에 대한 SDEA 이행여부 모니터링 REQUIREMENTS: 약학, 생물, 화학, 간호학 관련 전공 및 경력 MS Office사용 능숙 영어 가능 (중급이상)