Rohit Nikam
Medical Coder Associate
- Role
- Associate Medical Coder at WNS
- Location
- Nashik, MH, IN
- LinkedIn followers
- 500 followers
About Rohit Nikam
Good understanding of Clinical Research Process and ICH-GCP guidelines. • Comprehensive knowledgeof clinical data management( CRF designing, Validation, Data Collection, Data Storage, Data Validation,Query Management, Data Archiving, Quality Systems, SOPs and Audits, Query Resolution and DataCleaning, 21 CFR part 11 and Database Design) • Have good knowledge of Clinical Trial Management(ICH-GCP, Site Selection, Site Initiation,Terminologies, Schedule-Y, Phase I, II, & IV trials, Responsibilitiesof Monitor, CRA, CRC, Investigator, Sponsor, Protocol, Investigational Brochure, CRF, eCRF, Recruitment andEnrolment, CRF Completion and Submission, and Data Query Degeneration and Resolution, GoodUnderstanding of Regulatory guidelines in CR), BA / BE studies. • Comprehensive knowledge ofinternational drug safety and pharmacovigilance principles and process (ADR, Serious Adverse Reaction,SAE, MedDRA, Pharmacovigilance role, SUSAR, Case assessment (expectedness, casuality, expedited ofevent). • Reporting, documentation and archiving. • English • Computor Skills. Microsoft Excel, MicrosoftPowerPoint, Microsoft Word.
Experience
Associate Medical Coder
Sep 2024 — Present · Nashik, IN
Education
North Maharashtra University, Jalgaon
Bachelor of Pharmacy - BPharm
2018 — 2022
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