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About the Role
This role focuses on post-market safety management, involving the collection, review, evaluation, and reporting of safety information for domestic and international sources. It also includes managing customer communications, document reviews, risk assessments, and implementing safety measures.
Responsibilities
- Collect, review, evaluate, and report safety information related to domestic, literature, and infectious diseases within deadlines (15/30 days).
- Obtain additional information and respond to inquiries from overseas manufacturers.
- Adhere to deadlines for adverse event reporting and product returns.
- Collect, review, evaluate, and report safety information related to foreign cases and measures within deadlines (15/30 days).
- Create customer letters and handle inquiries related to them.
- Review new package inserts, create draft revisions, and manage revision schedules.
- Review instructions for use and marketing materials.
- Conduct pre-product launch risk assessments.
- Plan safety assurance measures and provide instructions to relevant departments (e.g., recall plans, information dissemination, patient monitoring).
- Analyze trends in domestic post-market malfunctions and collaborate with relevant departments (including manufacturers) to plan and implement quality maintenance measures.
- Collaborate with other departments during product launches, FCA, and projects.
- Manage external vendors related to safety management operations (package inserts, foreign measure information, literature information, etc.).
- Actively participate in projects such as process improvement and new process establishment.
- For Sr. Specialists: Provide guidance to team members and demonstrate superior processing capabilities compared to Specialists.
Requirements
- Ability to concisely summarize information and create easy-to-understand documents.
- Ability to coordinate with domestic related departments under the direction of a supervisor.
- Ability to prioritize multiple tasks and complete them by deadlines.
- Ability to understand English documents and communicate or negotiate with manufacturers via email or verbally.
- Possess technical foundational knowledge to understand analysis results and explain them to customers.
Skills
- Safety management information collection
- Safety information review
- Safety information evaluation
- Administrative reporting
- Customer communication
- Document review
- Risk assessment
- Safety assurance measure planning
- Trend analysis
- Process improvement
- Project management
- Vendor management
- English comprehension
- Negotiation
Location
- Japan > Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku
Work Type
- Standard
Experience Level
- Sr. Specialist
- Specialist
Salary/Compensations
- N/A
About the Company
- JOB FAMILY: Operations Quality
- DIVISION: EP Electrophysiology