[Hiring] Drug Safety Associate @ICON plc

Role Description

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.

• 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 teams.
• Provide technical and process oversight with respect to safety services for larger full service projects or smaller safety stand-alone projects.
• Ensure quality and consistency across multiple projects for one client.
• Support the SRM management team in the development of training courses as well as SOPs and associated documents.
• Participate 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

Qualifications

• 1 year 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.

Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

Company Description

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.