Safety Officer - Japan (安全管理責任者 – 日本)

SCOPE:

Based on the strategy of the U.S. headquarters, you will work in collaboration with the Quality Officer (Japan) to ensure that products manufactured and sold in Japan comply with the GVP Ordinance and GPSP Ordinance. Specifically, you will bear direct responsibility for post-marketing safety management activities in Japan, including post-marketing investigations. Additionally, you will collaborate with overseas manufacturing sites to ensure that Japan's post-marketing information is managed within the global vigilance system.

(米国本社のストラテジーを踏まえて、品質担当責任者(日本)と連携して、日本において製造販売する製品がGVP省令並びにGPSP省令に適合していることを確実にして頂きます。具体的には、製造販売後の調査を含めた、日本における製造販売後安全管理業務に直接的な責任を持って頂くと共に、海外製造所と協力して、グローバルビジランスシステムにおいて日本の製造販売後情報が管理されていることを確実にして頂きます。)

NOTE: Candidates being considered for this position must reside in Japan

PRIMARY RESPONSIBILITIES:

• Post-Marketing Safety Management Activities in Japan
  • Collection, analysis, and review of safety management information (spontaneous reports)
  • Collection, analysis, and review of country-specific action information and literature information
  • Implementation of safety assurance measures (administrative reporting, voluntary recalls, information provision, etc.)
  • Planning and implementation of education and training
  • Planning and implementation of self-inspections
  • Management of documents and records
  • Maintenance and management of GVP contracts

• 日本における製造販売後安全管理業務

  • 安全管理情報（自発報告）の収集・分析検討

  • 各国措置情報、文献情報の収集・分析検討

  • 安全確保措置（行政報告、自主回収、情報提供等）の実施

  • 教育訓練の計画・実施

  • 自己点検の計画・実施

  • 文書・記録の管理

  • GVP契約書の維持・管理

• Development and execution of risk management plans (including conducting post-marketing studies)

• リスク管理計画の立案及び実行（製造販売後調査の実施含む）

• Labeling Implementation and Maintenance (Creation, maintenance, and management of Product Label, IFU, and/or Ops Manual (including consultation with PMDA during revisions)

• ラベリング対応（製品表示ラベル、添付文書（取扱説明書含む）の作成・維持・管理（改訂時のPMDA相談対応含む）

• Other safety management-related tasks (including administrative/industry correspondence)

• その他安全管理に関する業務（行政／業界対応含む）

• Minimum of an Associate's degree (Bachelor's or Master’s degree preferred) in Science required
• Minimum 5 years’ experience in Medical Device Industry
• Effective project management and administration skills
• Highly organized, exhibiting meticulous attention to detail, excellent record keeping
• Excellent verbal, written, and analytical skills and ability to interact effectively with Sirtex staff

CERTIFICATION:

• Meeting the criteria of 安全管理責任者(Safety Officer), under Japan Pharma and Medical Device Act

TRAINING REQUIREMENTS:

• Undergo all formal Training Events as may be directed from time-to-time
• Observe and comply with all Sirtex Corporate Policies
• Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements
• Work within, and ensure adherence to Health, Safety and Environment Management System procedures, instructions and other requirements.

All your information will be kept confidential according to EEO guidelines.

Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people’s lives. Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success.

Sirtex offers qualified candidates:

• Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
• A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
• Attractive compensation and benefit packages which are practical, robust and equitable.
• A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
• Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
• An unwavering commitment to company values, employee safety and excellence in everything we do.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.

Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.