Dr. Pooja Singh (Pharm-D)

Medical Device Case Handling Performed processing of Product Quality Complaints in the Novo Nordisk complaint handling database NOVOGLOW. Performed case entry, verification and archival of the product quality complaints. Identified deviations and performed trending analysis. Handled cases in compliance with the GMP and SOP guidelines. Conducted QC of product quality complaint cases. Hands on experience with the tracking system PRISM and SAP.

Individual Case Safety Report processing Performed case triage, data entry, verification, processing and reporting of cases within timeline. Medical coding as per WHO-DD and MedDRA dictionary. Narrative writing and reporting of adverse drug reaction (ADR)/adverse event (AE) serious/non-serious cases in Argus database. Good knowledge and understanding of ICH-GCP guidelines, GVP VI module and applicable regulatory requirements.

Adverse Drug Reaction Monitoring and Reporting in a hospital setup as an Intern Monitored Adverse Drug Reaction (ADR) and adverse events (AE) in a hospital set-up. Evaluated cases causality based on WHO-UMC scale and Naranjo scale. Reported serious/non-serious ADR cases/AE via Center for Drug Standard Control (CDSCO forms) to the PVPI India.