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.
업무 책임:
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
자격 요건:
약학, 생물, 화학, 간호학 관련 전공 및 경력
MS Office사용 능숙
영어 가능 (중급이상)
제공 혜택:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others