Drug Safety Associate

Drug Safety Associate - Tokyo - Office

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 investigational drugs and contributing to the advancement of inNvative treatments and therapies.

What you will be doing

• Collect and review adverse event reports from clinical trials and post-marketing sources.

• Conduct initial assessment and coding of adverse events according to established procedures and regulatory guidelines.

• Prepare and submit expedited safety reports to regulatory authorities and investigators as required.

• Assist in the development and maintenance of safety databases and tracking systems.

• Collaborate with cross-functional teams to ensure timely and accurate reporting of safety data.

Drug Safety Associateとして外資クライアントのプロジェクトにて安全性情報（ラインリスト等）の作成および提供、医療機関から報告されたSAEの内容確認、データベース入力等に従事します。

Your profile

• Bachelor's degree in a scientific or healthcare-related field.

• 1-2 years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotechNlogy industry preferred.

• KNwledge of pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA).

• Strong attention to detail and ability to work effectively in a fast-paced environment.

• Excellent communication and organizational skills, with the ability to collaborate across teams and prioritize tasks efficiently.

• 理系のバックグラウンド
• GCPの知識・医薬品開発に関する2年程度の経験（CRA経験があれば尚可）
• プロジェクト遂行の読み書きに支障ない英語力

※医療機関への出張はありません

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