Pharmacovigilance Officer Japan
Description:
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.
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