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.

.

• 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)

#LI-office

#LI-SO1

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply