Nitin Pinjarkar

Quality Review and Subject Matter Expert (SME)

• Perform daily quality review (QR) for Individual Case Safety Reports (ICSR) by comparing source documents and the case information entered the safety database to ensure accurate and consistent data entry/quality. Coach/Train/Mentor.
• Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on accuracy, timeliness and quality.
• Worked over process simplification project with client collaboration.
• Additionally involved in quality improvement plans, mentorship of new joiners and trainings.
• Support in audits/inspection as Subject Matter Expert, and develop and implement Corrective and preventative Actions (CAPA) to address safety findings.
• Responsible for co-ordination with client for email communication as and when required for case processing related queries.

Data Entry Expert

Case processing of adverse event reports from source documents with emphasis on timeliness and quality. Use medical dictionaries (MedDRA, WHO DD and Company Drug Dictionary) and business guidance to code medical history, lab data, drugs and adverse event terms.

Perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in the safety database.

Assessing the validity of case.

Data entry of adverse event reports from source documents. Use medical dictionaries (MedDRA, WHO DD and Company Drug Dictionary) and business guidance to code medical history, lab data, drugs and adverse event terms.

Responsible for allocation of cases to all Data entry and QC Associates.

Responsible to prepare and submit AER and line lists (work status) and report to client on daily basis.

Medical coding,

Applications- Citrix , KF, COBRA.

Data processing and Management.