Key Facts

Remote From:

Full time

Mid-level (2-5 years)

English

Hard Skills

FDA Regulations Pharmacovigilance Safety Audits Report Generators Adverse Event Monitoring Medical Error Reporting Language Translation Safety Audits Database Security Active Safety +6 more

Other Skills

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Ability To Meet Deadlines
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Communication
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Time Management
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Detail Oriented

Roles & Responsibilities

1 year to 1.5 years of related experience
Undergraduate degree or international equivalent, preferably in life science, nursing, pharmacy and/or healthcare profession
Advanced knowledge in pharmacovigilance and the regulatory environment governing safety and risk management activities
Ability to work remotely from South Korea

Requirements:

Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for products from clinical trials, non-interventional studies, patient-oriented programs, literature and spontaneous reports
Transcribe, translate and enter data from source documents into safety systems accurately, with emphasis on timeliness and quality
Manage reporting, submission and distribution of safety reports/updates/information (e.g., SAE, SR, SUSAR, PSUR, DSUR) to local health authorities and/or clinical operations in cooperation with other clinical operations 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; support SRM management in the development of training courses and SOPs

ICON plc

Pharmaceuticals

About ICON plc

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

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.

#LI-remote

#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, 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