Abhishek Kumar Gupta

About Abhishek Kumar Gupta

Medical Device Vigilance(MDR), Medical Incident Report(MIR), Health Canada Report for Initial and Follow up reporting related to complaints handling process.Submission of reports to US FDA, receiving acknowledgement and performing SAP documentation for the same.Handling complaints of medical device class 2. Global complaints handling (IGT)Submission of reports in Trackwise, Final reporting and Initial reporting.End to end case processing in Trackwise (Initial reporting, final reporting, Investigation and Global decision tree)Medical Device Vigilance(MDR), Medical Incident Report(MIR), Health Canada Report for Initial and Follow up reporting related to complaints handling process. Submission of reports to US FDA, receiving acknowledgement and performing SAP documentation for the same. Handling complaints of medical device class 2. Global complaints handling (IGT) Submission of reports in Trackwise, Final reporting and Initial reporting. End to end case processing in Trackwise (Initial reporting, final reporting, Investigation and Global decision tree)Skills: Microsoft Excel · TrackWise · SAP PRD · WEBTRADER · Microsoft PowerPoint · Time Management.

Experience

1. Senior Safety Associate

   4c Pharma Solutions

   Apr 2025 — Present · Hyderabad, IN

   Analyzed and understood complaint scenarios to assign new failure codes to non-reportable complaints based on information provided by Field Service Engineer, ensuring compliance with Class II devices requirements.• Managed PMS Complaint Handling process including intake, evaluation, Follow-up, investigation and closure.• Conducted follow-ups to gather more information and handled product returns, identification of root cause and resolution to the reported events.• Demonstrated good knowledge of device regulatory requirements for Medical Devices including IS0 13485:2016, EU MDR, ISO 14971:2019, IEC 62304:2015, Risk Management, and FDA 21 CFR part 820.• Executed Failure coding, Event coding, and Hazard coding activities.• Submitted MIR, Health Canada and IRIS report.• Maintenance and reporting of Adverse Drug Experience (ADE) data and Adverse reaction data to Regulatory Authorities.• Worked for various GMP principles in SAP including Validation, Documentation and Quality Management System (QMS). • Executed Failure coding, Event coding, and Hazard coding activities.• Generated investigation summaries based on technical product analysis data for further review.• Reviewed, analyzed, and provided detailed rationales for reportable and non-reportable complaint scenarios.• Worked on different categories of medical devices like- Tempus Pro Monitor (Remote Diagnostic Technologies), Sleep and Respiratory care, Medical Resonance Imaging (MRI), Dental devices.• Worked under L1, L2 and L3 submission and Global Decision Tree (GDT) analysis.

Education

• Amity University Kolkata

  Msc Biotechnology, Dry and wet lab work