Pharmacovigilance Reporting Associate

2ヶ月前

Tokyo, Tokyo Nextrials, Inc.

Pharmacovigilance Reporting Associate Tokyo

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 Pharmacovigilance Reporting Associate to join our diverse and dynamic team. As a Pharmacovigilance Reporting Associate at ICON, you will be responsible for the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. You will ensure compliance with regulatory requirements and contribute to the effective management of safety data to support patient safety and regulatory compliance.

What You Will Be Doing

  • Preparing and reviewing safety reports, including periodic safety updates and individual case safety reports, ensuring accuracy and compliance with regulatory standards.
  • Collecting and analyzing adverse event data from clinical trials and post-marketing sources to support the preparation of comprehensive safety reports.
  • Maintaining up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting.
  • Collaborating with cross-functional teams, including clinical, regulatory, and data management, to gather necessary information and resolve any reporting issues.
  • Ensuring the timely submission of safety reports to regulatory authorities and sponsors, adhering to established deadlines and guidelines.

Your Profile

  • Bachelor's degree in life sciences, pharmacy, or a related field.
  • Experience in pharmacovigilance or drug safety, with a strong understanding of safety reporting processes and regulatory requirements.
  • Excellent attention to detail and organizational skills, with the ability to prepare and review complex safety reports accurately.
  • Strong communication and collaboration skills, with experience working effectively within a multidisciplinary team.
  • Ability to manage multiple tasks and prioritize effectively in a fast-paced, regulated environment.

職務内容

ICONでは、多様で活気あるチームの一員として、臨床試験および市販後の安全性情報の正確かつ迅速な報告を担当していただけるPharmacovigilance Reporting Associateを募集しています。規制要件を遵守し、安全性データの管理を通じて患者の安全性と規制遵守をサポートする重要な役割です。

具体的な業務内容は以下の通りです:

  • 個別症例安全報告(ICSR)や定期安全性更新報告書(PSUR)など、安全性報告書の作成・レビューを行い、正確性および規制基準への適合性を確保する
  • 臨床試験および市販後の有害事象データを収集・分析し、包括的な安全性報告書の作成を支援する
  • ファーマコビジランス報告に関連する規制要件や業界のベストプラクティスを常にアップデートする
  • 臨床、規制、データ管理などのクロスファンクショナルチームと連携し、必要情報の収集や報告上の課題解決を行う
  • 定められた期限とガイドラインに従い、安全性報告書を規制当局およびスポンサーへ適時提出する

応募資格

  • ライフサイエンス、薬学、または関連分野の学士号
  • ファーマコビジランスや医薬品安全性に関する経験、特に安全性報告プロセスおよび規制要件への理解
  • 高い注意力と組織力を有し、複雑な安全性報告書を正確に作成・レビューできる方
  • 優れたコミュニケーション力と協働力を持ち、学際的なチームでの業務経験がある方
  • 多数のタスクを効率的に管理し、優先順位をつけて業務を遂行できる方

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

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