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About the Role
This role focuses on post-marketing safety management, including collecting, reviewing, and evaluating safety information from domestic and international sources, as well as reporting to regulatory authorities.
Responsibilities
- Collect, review, and evaluate domestic, literature, and infectious disease safety management information, and submit reports to regulatory authorities within deadlines (15 days/30 days).
- Obtain additional information and respond to inquiries from overseas manufacturers.
- Adhere to deadlines for adverse event reporting and product returns.
- Collect, review, and evaluate foreign case and foreign measure safety management information, and submit reports to regulatory authorities within deadlines (15 days/30 days).
- Create customer letters, handle inquiries related to customer letters, and accompany customers.
- Review new package inserts, create draft revisions for package inserts, and manage revision schedules.
- Review instructions for use and marketing materials.
- Conduct pre-product launch risk assessments.
- Plan safety measures and provide instructions to relevant departments (e.g., recall/remediation, patient monitoring, information dissemination plans, creation of documents for safety measures, progress management of information dissemination/patient monitoring).
- Analyze trends in domestic post-marketing adverse events and collaborate with relevant departments (including manufacturers) to plan and implement quality maintenance measures.
- Collaborate with other departments (product launch, FCA, projects, etc.).
- 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, in addition to the above, provide guidance to team members and demonstrate processing capabilities exceeding those of a Specialist.
Requirements
- Ability to concisely summarize text/documents and create easy-to-understand materials.
- 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 and communicate or negotiate with manufacturers via email or orally.
- Possess technical foundational knowledge to understand analysis results and the ability to explain them to customers.
Skills
- Safety management information collection
- Safety management information review
- Safety management information evaluation
- Regulatory reporting
- Customer communication
- Document creation
- Risk assessment
- Process improvement
- Project management
- Vendor management
- Trend analysis
- English communication
Location
- Domestic
Work Type
- Full-time
Experience Level
- Specialist
- Sr. Specialist