Manager Pharmacovigilance 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 Manager, Pharmacovigilance to join our diverse and dynamic team. As the Senior Manager in this role at ICON, you will be responsible for overseeing pharmacovigilance activities to ensure the safety and efficacy of our clinical trials. Your leadership will be critical in maintaining compliance with regulatory requirements and enhancing the overall safety monitoring processes across the organization. 現在、ICONではご活躍いただけるファーマコビジランス マネージャーを募集しています。 本ポジションでは、治験における安全性と有効性を確保するため、ファーマコビジランス業務全般の管理をお任せします。 規制要件の遵守および安全性モニタリングプロセスの強化に向け、リーダーシップを発揮していただきます。 **What You Will Be Doing:** + Managing the pharmacovigilance team to ensure timely and accurate reporting of adverse events and safety data in compliance with regulatory standards. + Developing and implementing pharmacovigilance policies and procedures to enhance safety monitoring and risk management practices. + Collaborating with cross-functional teams, including clinical operations and regulatory affairs, to ensure integration of safety data into clinical development plans. + Monitoring and analyzing safety data trends to identify potential risks and inform decision-making for ongoing clinical trials. + Staying updated on industry regulations and best practices in pharmacovigilance to drive continuous improvement initiatives. **主な業務内容：** + ファーマコビジランスチームのマネジメント　– 有害事象および安全性データの報告を、規制基準に則り、正確かつ迅速に実施 + 安全性モニタリングおよびリスクマネジメントを強化するための　– ポリシーや手順の策定・導入 + 臨床開発計画への安全性データ統合に向けた　– 臨床オペレーション部門や薬事部門との連携 + 安全性データの傾向分析および潜在的リスクの特定　– 治験における意思決定のサポート + ファーマコビジランス分野における　– 最新の業界動向・規制要件の把握と継続的な改善活動の推進 **Your Profile:** + Degree in life sciences, pharmacy, or a related field; advanced degree or relevant certifications are preferred. + Significant experience in pharmacovigilance or drug safety, ideally within the clinical research or pharmaceutical industries. + Strong understanding of regulatory requirements related to drug safety and reporting. + Excellent analytical and problem-solving skills, with a focus on data-driven decision-making. + Strong communication and interpersonal skills, capable of engaging and influencing diverse stakeholders. **応募資格・求める人物像：** + 生命科学、薬学、または関連分野の学位（修士号や関連資格をお持ちの方は歓迎） + 製薬業界または臨床研究業界における、ファーマコビジランス／薬剤安全性業務の豊富なご経験 + 薬剤安全性に関する規制要件や報告義務の深い理解 + データに基づく意思決定ができる分析力・課題解決力 + 多様な関係者と円滑に連携し、影響力を発揮できるコミュニケーション能力 **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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations) 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 (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply