Pharmacovigilance Officer Japan

 

Pharmacovigilance Officer Japan

         

Your Tasks And Responsibilities:

• Executes a high-quality oversight of Pharmacovigilance (PV) governance by conducting below local process and compliance activities in alignment with global standards as well as Japanese regulation requirements
• Audit/Inspection, CAPA management
• QSD management
• Training and Archiving
• Outsourcing and PV Agreement management
• Maintain and/or implement below local risk management activities through product life cycle management in alignment with global standards as well as Japanese regulation requirements
• product benefit/risk management including Japan RMP (Risk Management Plan) with required RMP material, various periodic safety report, EPPV, and safety communication, etc.
• safety communication on appropriate use of Bayer products with necessary stakeholders
• Keep local process standardized, qualified and continuously improved to comply with the local regulatory requirements as well as global PV standards
• Support colleagues’ activities including peer advice, capability establishing, and developing to secure local PV competency, etc.
• Audit/Inspection, CAPA management
• QSD management
• Training and Archiving
• Outsourcing and PV Agreement management
• product benefit/risk management including Japan RMP (Risk Management Plan) with required RMP material, various periodic safety report, EPPV, and safety communication, etc.
• safety communication on appropriate use of Bayer products with necessary stakeholders

Who You Are:

• Bachelor‘s degree or above
• At least 3 years solid experience in pharmacovigilance activities  
• Good knowledge of medical terminology
• Ability to adhere to procedures
• Excellent administrative skills
• Detail minded and task-oriented person
• Strong sense of responsibility and conscientiousness, priority setting, organizing
• Stress resistance and ability to comply with strict deadlines
• Ability to build strong relationships both internally and externally, and communicate effectively with all levels of business stakeholders including strong verbal and written interaction with regulatory authorities, etc.
• Ability to solve problems and use strategic thinking to make decisions
• Fluent in Japanese and business-level English (TOEIC 730 or above as a guide) 
• Proficiency in MS Office applications and other IT systems

What Bayer Can Offer You:

• We offer a competitive a salary package consisting of an annual basic salary and Short-Term Incentive (STI) bonus and top performance award and so on, tailored to your role at Bayer
• We provide various special paid day-offs on top of given annual paid vacation days. Also, we promote work-life balance by offering employees flexible working hours and home-office arrangements depending on your job nature in alignment with your manager
• We support your professional growth by providing learning and development opportunities through training programs, regular feedback and project participations
• At Bayer, our employees are welcomed, supported, and encouraged to reach their full potential. We also embrace and respect diversity by providing an inclusive and fair work environment for all employees
• We provide various attractive corporate benefit programs for all of our valuable employees such as DC pension plan, health and medical support by Bayer Health Insurance Association, Benefit Club membership, and life insurance

      採用予定日: ASAP       部門: 医療用医薬品   勤務地: 大阪     職務領域: メディカルアフェアーズ＆ファーマコビジランス   ポジションの職務等級: VS1.1 - VS1.2     社員区分: 正社員   勤務時間: 09:00 - 17:30       連絡先   E-Mail     recruiter_jp@bayer.com