Core Responsibilities
- Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products,
biologics, and combination products, ensuring compliance with regulatory standards.
- Proficient in Japanese, facilitating the accurate interpretation and translation of Product Technical Complaints (PTCs) received from the respective countries.
- Collaborate with internal/external stakeholders via Cross functional teams (Manufacturing
sites, Customer Service, Medical Information, Pharmacovigilance, Regulatory, Legal, Field
Alert Reporting, risk management departments, etc.) (as applicable) for complaint
management.
- Conduct management of complaints into the proper database (as applicable) and perform
assessment, ensuring timely processing as per defined scope. Focus on operational tasks
within the complaint handling process.
- Ensure to complete all training in a timely manner and guarantee continuous improvement of the knowledge according to the annual training plan.
- Participate in ad-hoc meetings for product-specific complaint issues and provide timely
feedback to ensure all the data necessary for complaint investigation process.
- Ensure the compliance of documentation and all Quality processes according to applicable
regulations/ Sanofi standards. Handle Quality Management system (QMS) records by
applying data privacy regulations, manage any discrepancies, and ensure completion within
defined timelines.
- Ensure the documentation of Hub-related GxP activities.
- Proactively identify areas for improvement and support on the implementation.
- Abide any other responsibilities as assigned/aligned by manager.
For MCCQ – Regional hubs
- Act as a Regional hub for the assigned countries. Follow up with the complainant for additional information and complaint sample management (as applicable).
- Determine if the inquiry is associated with an Adverse Event, Pharmacovigilance (PV)
Special Situation, customer service or Field Alert Reporting-related information (as
applicable). Ensure respective teams are communicated, if required.
- Appropriate handling and closure (as applicable) of information considered as Non-PTC at Regional Level.
- Capture and document sample information into the proper fields of the system (as
applicable)
- Ensure to complete all the required information and forward the complaint to Global Hub
(including translation, if applicable).
- Health authority called-in complaints, prioritized complaints, and suspected counterfeit
complaints are handled with the utmost urgency and in strict compliance with both global
and country-specific regulatory requirement.
- Ensure acknowledgement of Complaint (as applicable). Communicate with the complainant for any other request/ additional information related to complaint, if required.
- Maintain compliance with all relevant regulatory requirements for complaint management
and reporting.
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