What are the responsibilities and job description for the Intern - Product Complaint Manufacturing & Supply Services position at sanofi?
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 Mandarin, 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. 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! We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.