Tokyo Parexel フルタイム

共通の価値観が一致すれば、無限大の可能性を切り開くことができます。

仕事内容

薬機法や安全性に関する規制、および社内の標準オペレーションハンドブック(SOP)に準拠し、国内外の医薬品・医療機器・再生医療等製品に関連する有害事象、副作用情報、不具合情報の収集、評価、報告を行う業務です。

具体的には次のような業務があります:

  • 国内における治験薬・製造販売後製品の安全性情報、文献学会の一次評価
  • CIOMSや文献学会情報等による海外(英語)安全性情報の一次評価、和訳
  • MRへの再調査指示業務サポート
  • 医薬品医療機器総合機構への(医薬品)副作用、研究報告、措置報告、不具合報告書(案)の作成
  • 経験に応じて、チームリーダーやクライアント窓口などを担当していただくこともあります。
  • その他、クライアントの指示命令事項

■必要条件

・治験薬または市販後薬品に関連する安全性関連業務経験2年以上あります。

・業務で英語を使用している場合

・Argusの使用経験がある場合



  • Tokyo Parexel フルタイム

    共通の価値観が一致すれば、無限大の可能性を切り開くことができます。 · ■仕事内容 · 薬機法や安全性に関する規制、および社内の標準オペレーションハンドブック(SOP)に準拠し、国内外の医薬品・医療機器・再生医療等製品に関連する有害事象、副作用情報、不具合情報の収集、評価、報告を行う業務です。 · 具体的には次のような業務があります: · 国内における治験薬・製造販売後製品の安全性情報、文献学会の一次評価 · CIOMSや文献学会情報等による海外(英語)安全性情報の一次評価、和訳 · MRへの再調査指示業務サポート · 医薬品医療機器総合機構への(医薬品 ...


  • Tokyo Thermo Fisher Scientific フルタイム

    Drug Supply Associateチームの一員として、すべてのお客様の注文を正確かつタイムリーに適切に処理する、意欲的な人材を募集しています。 お客様とのコミュニケーションとチームワークを重視し、複雑な問題を解決するチャンスと責任を持つことができます。 確立された手順を遵守することの重要性を理解し、チームをサポートするために、新しい問題や興味深い問題に取り組むアプローチも行っていただけます。 · 仕事内容 · チームの業務遂行能力を把握し、勤務時間内にどれだけのことができるかを現実的に考える。 · 会社・チームのビジョンをメンバーと共有し、明確な ...


  • Tokyo Regeneron Pharmaceuticals, Inc Full time

    Job Description · Senior Drug Safety Manager · We are seeking a highly motivated and independent Senior Drug Safety Manager to join our team. As a key member of our organization, you will be responsible for ensuring the integrity of our systems by collaborating with Japanese part ...


  • Chiyoda Kenvue

    Japan Country Safety Officer Associate manager-2407021560W Description What You Will Do · Japan Country Safety Officer is responsible for the coordination and execution of post-marketing safety management activities for JNTL Consumer health K.K.* to ensure that all of local r ...


  • Tokyo BioMarin jobs.contract_type_full_time-Regular

    Job Title: · Quality Technical Manager · Department / Cost Center: · External Quality / 687 · Reports to (Job Title): · Director, Drug Product Market Release · Job Code: · Location: · Japan office · SUMMARY DESCRIPTION · This position reports to the Director of Drug Product Marke ...


  • Tokyo Amazon Data Services Japan G.K. - B45 Full time

    About the Role · As a Regional Safety Engineer – DCPD, you will be responsible for supporting AWS Data Center Planning and Delivery (DCPD) programs in achieving health and safety goals and improving our safety culture. · Key Responsibilities: · Influence program development, fram ...


  • Tokyo Astellas Pharma Inc. Permanent

    Description · We are seeking a motivated and experienced professional to join our Clinical Operations Oncology team as a Clinical Trial Coordinator. The successful candidate will be responsible for assisting the Clinical Trial Lead(s) and Clinical Trial Manager(s) in the day-to-d ...


  • Tokyo Servier Local Assignement

    Role Description · We are seeking a dedicated and detail-oriented Medical Information Officer to join our team. · Main Responsibilities: · Provide product information to healthcare professionals, including doctors and pharmacists, by visiting hospitals and pharmacies, and present ...


  • Tokyo Adidas Full time

    Purpose: · Partner with Retail Back Office, Retail Stores and Retail Consumer Experience teams to execute company health and safety policies and ensure compliance to all applicable global, regional and local regulations across Retail Back Office and Retail Stores in Japan. · Ke ...


  • Tokyo Capital Group Full time

    Operations/Facilities Manager · You will work as a first-level manager under limited direction, responsible for the Tokyo site's day-to-day operations and physical office environment. Lead and manage a team to execute daily activities within the site(s) and enhance the work exper ...


  • Tokyo Abbott

    Job Title: Quality Projects Specialist · Primary Function/Goals/Objectives: · You will report to the Regional Quality Manager within the International Third Party Manufacturing Division of Abbott Nutrition. Your role will provide ongoing quality support for third-party manufactur ...


  • Tokyo Thermo Fisher Scientific Full time

    Business Development Associate · About the Role: · Develop a strong understanding of new customers and their marketplaces through diverse information sources. · Identify and lead new business opportunities with customers. · Dig up and evaluate potential business opportunities for ...


  • Tokyo Pfizer Full time

    Position Purpose · Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. In this position, you will: · Provide leadership to ...


  • Tokyo Abbott

    Main Purpose of Role: · We are seeking a highly skilled specialist to join our Medical Affairs team. The ideal candidate will possess in-depth knowledge and expertise in the field of Medical Affairs, with the ability to execute complex projects and develop innovative solutions. · ...


  • Tokyo Abbott

    Main Purpose of Role · To oversee the effective implementation and maintenance of Quality Systems within Abbott Japan, ensuring awareness and continual improvement across the local organization. · Main Responsibilities: · Ensure compliance with commercial site requirements to loc ...


  • Tokyo Eureka Full time

    At Match Group (NASDAQ: MTCH), millions of members use our products every month and our customers go on tens of thousands of dates every single day. Our reach and impact are staggering. We believe that no business brings more happiness to more people than ours; we can never forge ...


  • Tokyo Amazon Data Services Japan G.K. Full time

    The Data Center Senior Construction Manager (CM) is responsible for managing the most technical, cost-efficient, and fast-paced construction project schedules achievable. Amazon Construction Managers are constantly challenged to drive continuous improvement and deliver the highes ...


  • Tokyo Gilead Sciences Regular

    Job Title: Associate Director, Medical Affairs Strategy · We are seeking an experienced and skilled Associate Director to join our Medical Affairs team in Japan. This role will be responsible for developing and executing the medical strategy and tactics for designated Cell Therap ...


  • Tokyo Motorola Solutions Full time

    Job Description · This role is for an experienced individual sales contributor, fulfilling through our defined Distribution and Channel partners in Japan. · Responsible for solution sales selling Motorola's Safety and Security Ecosystem inclusive of AAS Voice, Video and associate ...

  • Project Manager

    1週間前


    Tokyo HITACHI ENERGY JAPAN, LTD. Full time

    Description · : Mission statement: · You will lead the execution of small to large and complex projects and ensure that all related activities are performed in accordance with Hitachi Energy Japan policy, contractual agreements, quality standards, health, safety & environment ...


  • Tokyo Amazon Data Services Japan G.K. Full time

    About the Job · This Pre-Construction Manager role will be based in Tokyo, overseeing all pre-construction projects within North Asia. Amazon's Data Centers are renowned for innovation in security, safety, space utilization, efficiency, and cost-effectiveness. · We are the global ...