Rohan Kumbhar
Argus | Oracle AERS | MedDRA | WHO-DD |PV Compliance | Safety Database Tools | E2B Reporting | Safety reconciliation|End of line QC
- Role
- Operations Specialist 2 at IQVIA India
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Rohan Kumbhar
Individual case safety report processor (pharmacovigilance), multispeciality medical coder (ICD, CPT & HCPCS) and clinical coder (MedDRA & WHODD)
Experience
Operations Specialist 2
Jun 2021 — Present
Pharmacovigilance & Clinical Safety Expertise: Pharmacovigilance professional with10+ years of experience across ICSR processing, medical coding (MedDRA & WHODD), quality review, clinical trial safety, and regulatory compliance in global CROenvironments.• ICSR Lifecycle & Reconciliation: Strong expertise in end-to-end ICSR lifecyclemanagement, including Safety vs Clinical database reconciliation and EDC–PVreconciliation (RSG), ensuring data accuracy and compliance.• Audit Readiness & Quality Systems: Proven capability in audit readiness, root causeanalysis (RCA), and CAPA management, supporting regulatory inspections andmaintaining high safety and quality standards
Education
MAHATMA GANDHI VIDYAMANDIR
SSC, life science
2005 — 2007
Shivaji University
B.PHARMACY, Pharmacy
2007 — 2011
Skills
- Microsoft Excel
- Pharmacovigilance
- Team Management
- Clinical Research
- Microsoft Office
- Healthcare
- Sas Programming
- Regulatory Affairs
- Medical Coding
- Pharmacy
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