• Location: Kuala Lumpur, Malaysia
• Job Type: Full time, permanent
• Work Arrangement: Hybrid

Core responsibilities:

• Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products,

biologics, and combination products, ensuring compliance with regulatory standards.

• 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.

• Periodically prepare Key Performance Indicators (KPIs) data for meetings.

• Support on additional continuous improvement & team initiatives/projects.

• Abide any other responsibilities as assigned/aligned by manager.

Other accountabilities

For MCCQ ☒

• Create/Review the inquiry, Translate to English (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.

• Follow up with the complainant for additional information and complaint sample management

(as applicable).

• Appropriate handling, review and closure (as applicable) of information considered as Non-

PTC.

• Capture and document sample information into the proper fields of the system (as applicable)

• Ensure to complete all the required information

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.

• Categorize Product Technical Complaint (PTC) based on its potential impact on product quality or patient safety as per defined timelines.

• Recording of complaint details in global system including defective quantity / verify lot number.

• Categorize and process the Fast track complaint based on defined criteria.

• Sample management- request for sample collection, update sample/picture information in global system

• Ensure to complete all the required fields in tools and assign the complaint to respective investigation owning site.

• Ensure completion of the investigation. Perform final review/update the complaint record and close as per defined timelines.

• Ensure acknowledgement of Complaint and/or response letter to Complainant (As applicable).

• Maintain compliance with all relevant regulatory requirements for complaint management and reporting.

• Consulting to FAR team in case of any filed alert expected (as applicable).

• Process Toll out manufacturing complaints in QualiPSO (Intake and closure) – As applicable.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!