Gayathri Tirumalanadhuni
PMS Analyst
Rajahmundry,Andhra Pradesh
Summary
Accomplished PMS Analyst with a proven track record at HCL Tech, specializing in post-market surveillance and medical device complaints handling. Recognized for exceptional problem-solving skills and awarded for outstanding performance, demonstrating a commitment to quality and stakeholder satisfaction.
Overview
3
3
years of professional experience
Work History
PMS Analyst
HCL Tech
Madurai
11.2021 - Current
- Proven experience in complaint intake, investigation process, MDR submission, MIR submission, Quality check and final closure.
- Handled complaints on business units like peripheral interventions, urinary critical care,surgery, diabetic care, medical management systems, medical delivery systems, infusion speciality disposables.
- Served as a subject matter expert for Alaris infusion pumps.
- Expertise in handling of complaints through TrackWise tool, SAP, Salesforce, Smax, BDBEN4 and SAP4HANA.
- Performed critical end to end business processes including Reportability Determination, MDR Submission, Complaint History Review, Device History Review, Risk assessment, Return Sample Analysis Review, Root Cause Determination, Investigation Summary Write up, CAPA, IMDRF Annex A, B, C, D, E, F, G codes determination.
- Managed stakeholder expectations through regular presentations, status reports, and issue resolution discussions during the course of projects.
- Conferred with “knowledges Champion” and “productivity Leader” awards for continuous top notch performance throughout my tenure in the organisation.
- Handled complaints from various regions like Europe, Middle East Asia, Latin America, United States.
Education
B Pharmacy - Bachelor of Science
Aditya College of Pharmacy
Kakinada, Andhra Pradesh08.2021
Intermediate -
Sri Chaitanya Educational Institutions
Vijayawada, Andhra Pradesh04.2017
Skills
TrackWise
Languages
English
Bilingual or Proficient (C2)
Telugu
Bilingual or Proficient (C2)
Hindi
Upper intermediate (B2)
Tamil
Intermediate (B1)
German
Beginner (A1)
Accomplishments
- ERS Knowledge Champion
- ERS Productivity Leader
Timeline
PMS Analyst
HCL Tech
11.2021 - Current
B Pharmacy - Bachelor of Science
Aditya College of Pharmacy
Intermediate -
Sri Chaitanya Educational Institutions
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