Drug Safety Associate

Drug Safety Associate -Pharmacovigilance Role-Home 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

We are currently seeking a Drug Safety Associate to join our diverse and dynamic team. As a Drug Safety Associate at ICON, you will play a pivotal role in ensuring the safety of drugs.

What you will be doing

• Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all products from clinical trials, non-interventional studies, patient oriented programs, literature, spontaneous reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
• Manage reporting/submission/distribution of safety reports/updates/information(e.g. SAE, SR, SUSAR, PSUR, DSUR..etc) to local health authorities and/or clinical operations in cooperation with other clinical operation team.
• In addition to the above:
  • Provides technical and process oversight with respect to safety services for larger full service projects or smaller safety stand-alone projects
  • Ensures quality and consistency across multiple projects for one client.
  • Supports the SRM management team in the development of training courses as well as SOPs and associated documents
  • Participates in the Safety and Risk Management Regulatory Intelligence activities, to retrieve and maintain a global repository of regulatory safety reporting requirements 

• 개별 사례안전보고서 (수신된 ICSR추적, 회사 또는 고객 안전 DB에 입력, 쿼리 관리)
• 통합안전보고서 생성지원 (약물별 정기 보고 support)
• 클라이언트의 라이센스 파트너에게 안전 보고서 제출
• 약물감시 매뉴얼 개정 또는 제정 협업

Your profile

• 1year or 1.5 years experience of related experience
• Undergraduate degree or its international equivalent, preferably in life science, Nursing, Pharmacy and/or healthcare professional.
• Advanced knowledge in Pharmacovigilance and the regulatory environment governing safety and risk management activities.

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What ICON can offer you:

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.

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