PRITI GUPTA

• Define key risk indicators (KRIs) in study system and ensure consistency between the standard level and the study level. • Ensure RBM system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements. • Work with Study Team to define the issue resolution for the reviewing findings as signal and action. • Develop, implement and maintain Quality Control related documentations for RBM related activities (Cluepoints) to ensure data completeness and accuracy.

Review all comments and actions from EDC system queries, LSH/ECE discrepancy management, CDD/LEX checks, listings, Clean Patient Tracker. Follow-up with appropriate parties (e.g.study team, vendors, etc.) on issues unresolved by DM activities. Review and maintain study documentation, including completeness, accuracy, and performing periodic review of eTMF/TMF.

Serve as a Subject Level Data reviewer (SLDR) and identify any anomalies in patient reported data by performing Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy. Review all reported Adverse Events (AEs), Concomitant Medication and medical history information to ensure all supporting information is expected and/or implausible data is verified and adherence to protocol expectations.

• Working in Regulatory Process - GSK Pharma, Vaccines and medical devices related products. • Support Global Regulatory affairs in maintaining Regulatory information management system (RIMS) (Liquent Insight) • Improve accuracy of registration information in database through data quality reviews and streamline management of all pharmaceutical product registration data.

Experience of working in Bacteriology Department, Mycobacteriology, Parasitology and Mycology Lab which includes isolation, Identification and AST of Aerobic and Anaerobic organisms from various body sample including CSF and Blood. Experience of Working with BACTEC, Microscan and Vitek.

Total Quality Management

Microbiology

Microbiology