Aman Ahmed
Medical device - MDR Analyst | PMS - Complaints Handling | Vigilance reporting specialist | Salesforce, SAP, TrackWise | Masters in Pharmaceutical Regulatory Affairs
- Role
- Reporting & Data Analyst at HCLTech
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Aman Ahmed
Aman is a pharmacist by profession and has over 2 years of experience in the healthcare…
Experience
Reporting & Data Analyst
Jun 2025 — Present · Hyderabad, IN
Core Responsibilties - Complaint Owner & Investigator - Utilize tools such as GCHS (Global Complaint Handling System) for case processing, documentation, and reporting.Primarily responsible for MDR (Medical Device Reporting).Performs reportability assessments for global medical device complaints, ensuring compliance with EU MDR, US FDA, and other international regulatory requirements.Applies decision tree methodology to evaluate complaint cases and determine mandatory reporting obligations.Prepare and submit Medical Device Vigilance (MDV) reports within regulatory timelines.Collaborate with cross-functional teams (safety, quality, regulatory) to ensure accurate complaint evaluation and risk assessment.Maintain high standards of Good Documentation Practice (GDP) and compliance with ISO 13485, ISO 14971 frameworks.
Education
Jawaharlal Nehru Technological University Hyderabad (JNTUH)
M Pharm, Pharmaceutical Regulatory Affairs
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