About the role

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:

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, 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.

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

Aplyr's read

ICON plc is a leading global provider of outsourced services in the pharmaceutical industry, attracting professionals in clinical research and data management.
Synthesized from recent postings & public sources

What's promising

•ICON plc has a strong global presence, enhancing its ability to manage international clinical trials effectively.
•The company offers diverse career opportunities across various roles in clinical research and data analysis.
•ICON's focus on innovation in pharmaceutical services supports its competitive edge in the industry.

What to watch

•The pharmaceutical industry is highly regulated, which may limit flexibility in project execution.
•ICON's reliance on large pharmaceutical clients could pose risks if partnerships dissolve.
•The competitive nature of the CRO market may pressure ICON to maintain cost efficiency.

Why ICON plc

•ICON plc specializes in comprehensive outsourcing solutions, differentiating it from competitors with narrower service scopes.
•The company's integration of technology in clinical trials offers a unique advantage in data management.
•ICON's strategic acquisitions have expanded its capabilities and market reach significantly.

Aplyr’s read is generated by AI from public sources. Was it useful?

About ICON plc

ICON plc

iconplc.com

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ICON plc is a global provider of outsourced development and commercialisation services to the pharmaceutical, biotechnology, and medical device industries.