Intern - Product Complaint Manufacturing & Supply Services at Sanofi

Chengdu, Sichuan, China -

Full Time

Start Date

Immediate

Expiry Date

23 Jul, 26

Salary

0.0

Posted On

24 Apr, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Product Technical Complaints, Regulatory Compliance, Mandarin, Translation, Complaint Management, Data Privacy, Quality Management System, GxP, Pharmacovigilance, Risk Management, Documentation, Stakeholder Collaboration, Medical Devices, Pharmaceuticals, Biologics, Combination Products

Industry

Description

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! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The intern will manage product technical complaints for medical devices and pharmaceuticals while ensuring regulatory compliance and accurate translation. They will collaborate with cross-functional teams to process complaints, maintain database records, and support quality management system activities.