Debpratim Chakraborty
Post Market Surveillance | Global Complaint Handling| Medical Device Vigilance | FDA & EU Reporting | TrackWise | Regulatory Affairs | 5.5+ Years
- Role
- Senior Safety Associate at 4c Pharma Solutions
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Debpratim Chakraborty
Results-driven Senior Safety Associate with 5.5+ years of experience in Medical Device Vigilance, Pharmacovigilance, and Regulatory Affairs. Currently working with 4C Drug Safety Services, specializing in post-marketing surveillance, Individual Safety Case Report (ISCR) submissions, and global regulatory compliance (FDA, EU, Australia, Canada, ROW).Proficient in SAP HHS, E-Submitter, and regulatory tools with strong expertise in complaint handling, case processing, and device safety reporting. Experienced in FDA coding, 1:1 mapping of clinical signs & symptoms, device problem codes, and investigation findings.Demonstrated ability to maintain 100% compliance and productivity while handling high-volume safety data and submissions. Strong understanding of global regulatory frameworks and quality standards.Key Skills:• Medical Device Vigilance• Pharmacovigilance• ISCR / ICSR Processing• Regulatory Submissions (FDA, EU, ROW)• SAP HHS / E-Submitter• Complaint Handling & CAPA• Post-Marketing Surveillance• Drug Safety & Risk ManagementCurrently open to opportunities in Pharmacovigilance, Medical Device Safety, and Regulatory Affairs roles.
Experience
Senior Safety Associate
Jun 2024 — Present · Hyderabad, IN
Education
Maulana Abul Kalam Azad University of Technology, West Bengal formerly WBUT
Bachelor of Pharmacy - BPharm, Pharmacy
2016 — 2020
Arena Animation
Certificate, VFX
CISCE
high school , Biology/Biological Sciences, General
2014 — 2016
Arena Animation
Diploma in Graphic Designing, Graphic Design
Symbiosis Institute of Management Studies
Executive MBA, Operations & Supply Chain Logistic Management
Arena Animation
Professional Certification, Audio Video Editing
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