Lekha Sree

Results-driven Post-Market Surveillance Analyst with 3 years of experience in medical device complaint management, investigation support, and documentation. Demonstrated ability to handle high-volume workloads, maintain accuracy, and coordinate seamlessly with cross-functional teams to deliver high-quality outcomes in dynamic environments.

Post Market Surveillance (PMS) Analyst - HCL Technologies (Pvt) Ltd

(2021-01 - 2024-12)

BD-Integrated Diagnostic Solutions

• Managed global medical device complaints across the full lifecycle including intake, investigation, documentation, and closure.
• Conducted complaint investigations and root-cause reviews while ensuring accurate and complete documentation.
• Performed key activities such as technical writing, Grid Updates, Complaint investigation, Reopen Requests, and Cancellations within required timelines.
• Prepared and submitted daily TrackWise IDS reports covering specimen status, investigation progress, and overall complaint updates.
• Coordinated with Product Quality Engineers and cross-functional teams to gather missing information and support timely complaint resolution.
• Reviewed and validated incoming complaint details prior to progressing cases to the investigation stage.
• Supported trend analysis, scorecard preparation, and other complaint-related risk-management activities.
• Identified data inconsistencies and contributed to improvements in documentation quality and data validation processes.

Master of Science - Bio-Technology - Sri Ramachandra University (Chennai) (2017-01 - 2019-12)

Bachelor in Science - Bio-Technology - D.G. Vaishnav College (Chennai) (2014-01 - 2017-12)