Anjali Sahu

Medical Device professional with 4+ years of experience in Post Market Surveillance (PMS), Complaint Handling, and Vigilance Reporting. Currently working as PMS Analyst (CO/CI Specialist) at HCLTech. Expertise in end-to-end complaint lifecycle, coding, investigation, GFE, regulatory compliance, and closure aligned with FDA (21 CFR 803), ISO 13485, and MDR.

PMS Analyst (Complaint Owner & Investigator) - HCLTech

(2025-08)

• End-to-end complaint handling: intake → categorization → coding → investigation → summary → closure
• Manage CO/CI activities ensuring SLA compliance
• Perform root cause analysis (5 Why, Fishbone)
• Handle GFE activities and regulatory documentation
• Ensure compliance with FDA 21 CFR 803
• Tools: SAP, TrackWise, Power BI (basic)

Medical Device Vigilance Specialist - Wipro

(2022-02 - 2025-07)

• Investigated complaints and adverse events
• Submitted FDA MedWatch (3500A) reports
• Worked as GFE specialist
• MDR compliance and SAP documentation

Bachelor of Pharmacy - Pharmacy - Jeypore College of Pharmacy (2017 - 2021)