Sayani Sarkhel
PMS Analyst at HCL technologies (BD- Becton and Dickinson)Ex-Clinical Data Annotator in Medical AI at Imerit Tecnology| Ex-Senior Associate at Wipro | Vigilance and medical devices reporting specialist| ISO 13485|
- Role
- Lead Engineer at HCLTech
- Location
- Kolkata, WB, IN
- LinkedIn followers
- 500 followers
About Sayani Sarkhel
Worked in Wipro limited as a complaint handling specialist in medical device reporting having experience of 2.1 years in pharmacovigilance and medical devices. Worked as Senior associate in Philips SRC Project. Working on mainly AER (Adverse event reporting) and SAP application, submit the report to FDA.Experienced quality professional as a medical device complaint investigator for Sleep Respiratory, Oxygen and ventilator devices. Specialized on Medical Device Reporting, Adverse Event Reporting, initial review for repotability of complaints, Good Faith Efforts(GFE) and Follow-ups of additional information, having operational skills in Trackwise, E- Submitter, Power BI and SAP.
Experience
Lead Engineer
Mar 2025 — Present · Madurai, IN
Complaint Handling, Medical device reporting, 21 CFRPost Marketing Surveillance Complaint ManagementISO 13584Managing Post market product complaints in compliance with EUMDR, FDAOversee complaint intake, investigation, documentation upto closure and regulatory reporting.Collaborate cross functionality to drive CAPA and product improvement.
Education
Bengal College of Pharmaceutical Sciences and Research 242
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
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