Job Description

Pharmacovigilance Reporting Associate

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.

ファーマコビジランス レポーティング アソシエイト 募集中

ICONでは、多様性に富んだ活気あるチームの一員としてご活躍いただける ファーマコビジランス レポーティング アソシエイト を募集しています。このポジションでは、治験および市販後の活動に関連する安全性報告書の正確かつ迅速な作成をご担当いただきます。規制要件の遵守を徹底し、患者の安全確保および規制コンプライアンスの推進に貢献していただきます。

業務内容：

• 定期的な安全性更新報告書（PSUR）および個別症例安全性報告書（ICSR）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

• 治験および市販後の情報源から有害事象データを収集・分析し、総合的な安全性報告書の作成をサポートする

• ファーマコビジランスに関する規制要件および業界のベストプラクティスについて常に最新の知識を維持する

• 臨床、規制、データマネジメントなどの他部門と連携し、必要な情報を収集、課題を解決する

• 規定さ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にタイムリーに提出する

応募要件：

• 生命科学、薬学、または関連分野の学士号を有する方

• ファーマコビジランスまたはドラッグセーフティに関する経験があり、安全性報告プロセスおよび規制要件に精通していること

• 複雑な安全性報告書を正確に作成・レビューできる優れた注意力および組織能力

• 学際的なチームで効果的に業務を遂行できるコミュニケーション能力および協調性

• 規制された迅速な環境下で複数の業務を効率よく管理・優先順位づけできる能力

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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