Sanket Saha
Business Analyst ||Regulatory Affairs (RA/QA)|| PMS || Medical Device (MDR Analyst) || EX - Wipro (Senior Associate) Complaint Handling || EX- Macleods (Jr. Officer - Production)||
- Role
- Business Analyst at Genpact
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Sanket Saha
A Registered pharmacist.\"Business analyst with expertise in the medical domain…
Experience
Business Analyst
Jan 2024 — Present · Gurugram, IN
Expertise of processing and submission of regulatory safety reports for USA, EU and ROW countries (MedWatch-3500A, EU-MIR, Health Canada, and IRIS etc.), in compliance with regulatory guidelines.• Experienced in Triage process to differentiate between Reportable and non-reportable complaints and determine the reportability decision of Serious and Non-Serious events in accordance with the severity level.• Knowledgeable on IMDRF coding conventions for various codes( Health Effect: Clinical Code, Health Effect : Impact Code, Medical Device Problem Code, Investigation Results etc.) • Experienced in closure of the complaints, ensuring all the aspects have been full filled as per the regulatory requirements.• Performed QC of all types of serious and nonserious cases, replacement product and other related duties as directed by management. • Identified as a process trainer in the team to train and mentor the newly joined resources.
Education
Sant nandlal smriti vidya mandir
Higher secondary
2008 — 2014
Bharati Vidyapeeth, Pune
Master of Business Administration - MBA
2024 — 2026
Central karima +2 high school
Intermediate
2014 — 2016
Biju Patnaik University of Technology, Odisha
Bachelor of Pharmacy - BPharm
Seemanta Institute of Pharmaceutical Sciences (SIPS), Jharpokharia, Mayurbhanj
Bachelor of Pharmacy - B.Pharm
2016 — 2020
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