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mukesh bairagi

@mukeshbairagi

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I improve clinical data quality through MedDRA coding, safety reconciliation, and ICH-GCP compliance.

India

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What I'm looking for

I'm seeking a remote Clinical Data Manager role where I can support data review, reconciliation, medical coding oversight, and compliant data deliverables while building hands-on depth with EDC systems and CDISC standards.

I'm applying my decade of case-level clinical safety data experience to clinical data management, including MedDRA coding, adverse-event reconciliation, and discrepancy resolution.

In my current Hospital and Clinical Pharmacist role with the Medical and Health Department, I collaborate with medical reviewers on signal detection, review case-level records for data-quality issues, and maintain audit-ready documentation under ICH-GCP and ALCOA+ principles. I've also supported EHR data integration, trial-process automation, and participant inclusion/exclusion criteria.

My M.Pharma in Quality Assurance and published work using statistical process control and Minitab reinforce my quantitative, data-integrity-focused approach to compliant clinical data deliverables.

Experience

Work history, roles, and key accomplishments

Current

Hospital and Clinical Pharmacist I

Current

Medical and Health Department

Sep 2012 - Present (13 years 11 months)

Performed accurate MedDRA coding of adverse events and drug indications, ensuring case-count accuracy and cross-record consistency. Collaborated with medical reviewers to support signal detection and resolve data-quality issues in line with ICH-GCP and ALCOA+ principles.

MedDRA Coding Data Reconciliation ICH GCP Signal Detection Inclusion Exclusion Criteria Microsoft Word

Continuous Quality Improvement Intern

Ranbaxy Laboratories

Nov 2011 - May 2012 (6 months)

Applied statistical process control using Minitab to analyze process deviations and Critical Quality Attributes, identifying data trends and quantifying process capability. Contributed to a peer-reviewed publication on statistical process control.

Minitab Data Analysis Quality Assurance