Core responsibilities:
1. Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products,
biologics, and combination products, ensuring compliance with regulatory standards.
2. Proficient in Korean, facilitating the accurate interpretation and translation of Product Technical Complaints (PTCs) received from the respective countries.
3. 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.
4. 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.
5. Ensure to complete all training in a timely manner and guarantee continuous improvement of the knowledge according to the annual training plan.
6. Participate in ad-hoc meetings for product-specific complaint issues and provide timely
feedback to ensure all the data necessary for complaint investigation process.
7. 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.
8. Ensure the documentation of Hub-related GxP activities.
9. Proactively identify areas for improvement and support on the implementation.
10. Abide any other responsibilities as assigned/aligned by manager.
For MCCQ – Regional hubs
1. Act as a Regional hub for the assigned countries. Follow up with the complainant for additional information and complaint sample management (as applicable).
2. 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.
3. Appropriate handling and closure (as applicable) of information considered as Non-PTC at Regional Level.
4. Capture and document sample information into the proper fields of the system (as
applicable)
5. Ensure to complete all the required information and forward the complaint to Global Hub
(including translation, if applicable).
6. 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.
7. Ensure acknowledgement of Complaint (as applicable). Communicate with the complainant for any other request/ additional information related to complaint, if required.
8. Maintain compliance with all relevant regulatory requirements for complaint management
and reporting.
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