BRAHMAJI KATTA

Experienced in working on safety database ARGUS and MedDRA.

• Currently working on Literature, Vaccine and NCS case processing and quality review.
• Well versed with Pharmacovigilance concepts and Reporting guidelines with knowledge of ICH guidelines.
• Trained in Case Processing, Coding and narrative writing.
• Trained in case entry of Literature, Vaccine and NCS cases.
• Assessment of case reports for seriousness, causality, and expectedness.
• Knowledge of domain, processes and global regulations governing pharmacovigilance and risk management.
• Good knowledge on MedDRA used in Pharmacovigilance
• Good clinical and scientific judgment.

AS QUALITY REVIEWER (Dec 2021 – Aug 2022)

• Evaluate case for accuracy, consistency and completeness in the safety database against case processing guidance documents.
• Monitoring processing of serious adverse event reports to meet internal and regulatory timelines as applicable.
• Review case narratives and company comment of the adverse event reports.
• Analyze cases to distinguish those with complexities or specific issues and escalate appropriately.
• Review case criteria to determine the appropriate workflow for safety case processing.

AS CASE PROCESSOR (FEB 2021 – DEC 2021)

Perform duplicate checks of cases following validation criteria for adverse event reports.
Enter cases according to prioritization criteria and regulatory timelines.
Responsible for entering individual case safety reports, coding medical history, events, drugs/procedures/indications, and laboratory tests using MedDRA, Company Product Dictionary, WHO-DD, and narratives in ARGUS database.
Review and evaluate adverse event case information to assess seriousness and determine necessary actions based on internal policies.
Enter and code case data, including event details, seriousness, reported causality, medical history, and laboratory data provided by reporters.
Provide required narratives as needed.
Initiate follow-up activities to clarify and gather additional information.
Forward cases for review or invalid workflow in the global safety database.
Conduct self-reviews to ensure accuracy, consistency, and completeness in the safety database compared to source documents.