Seasoned healthcare professional with expertise in denial management, seeking new opportunities in the healthcare sector. Demonstrating a comprehensive understanding of denial management intricacies, successfully navigating complex reimbursement processes and maximizing revenue for healthcare organizations. Certifications in pharmacovigilance ,Medical coding and clinical research showcase dedication to staying current with industry best practices. Two years of experience contribute to a desire to bring skills and expertise to a dynamic healthcare team.
Clinical Trial Management, ICH-GCP, Phases of Clinical Trial, Essential Documents, Drug Development. Process, ADR, SeriousAdverse Reaction, SAE, MedDRA, Adverse Drug, Schedule Y
ICH-GCP, Site Selection, Site Initiation, Terminologies, Schedule-Y, ICMR Guidelines, PhaseI, II, III & IV trials, Responsibilities of Monitor, CTA, CRA, CRC, Investigator, Sponsor, Protocol, Investigational Brochure, CRF, eCRF, Recruitment and Enrolment, CRF Completion andSubmission, and Data Query Degeneration and Resolution, Good Understanding of Regulatory guidelines inCR.
Electronic Data Capture , CRF designing, Validation, Coding, Clinical Data Management (ProcessFlow), Data Collection, Data Load/Transfer, Data Storage, Data Validation, Data Export (SDTM), Query Management, Data Archiving , Quality Systems, SOPs and Audits, Query resolution and data cleaning, Clinical Database Management System, Oracle Clinical® overview, EDC, 21 CFR part 11and SDTM overview, Database design and CRF annotation, Data entry and datacollection including Data transfer and Batch data load.
ADR, Serious Adverse Reaction, SAE, MedDRA, Risk Management, Pharmacovigilancerole, adverse drug reaction, SUSAR, ICH guidelines, Schedule Y, Adverse event reporting( medwatchform), Case process unit/ data entry ( triage unit), Case assessment ( expectedness, casuality, expedited of event),Narrative writing, Medical Terminologies.
Safety Writing, Regulatory Writing, Clinical Writing, Medical Communication, Regulatory Affairs, Regulatory Submissions
I hereby declare that the above stated information is true as per my knowledge