Kavitha Chenna Email & Phone Number

India

Bengaluru, Karnataka, India

Bengaluru Area, India

• Good understanding of Good Pharmacovigilance Practices (GPvP), 21 CFR Part 11.• Exposure to pharmacovigilance domain and drug safety applications (ARGUS)• Continuous review of applicable regulatory guidelines and SOPs on ICSR Processing• Good understanding of the regulatory guidelines of FDA, EMA• Responsible for Understanding the business requirements around Pharmacovigilance Regulatory • Involved in defining SOPs, User manual, Test protocol, Traceability Matrix,• Involved in root cause analysis on process deviation.• Involved in preparation and review of test summary report.• Experience of test management tools using Jira

Bengaluru Area, India

• Experience in system validation, change management and Quality Assurance.• Involved in defining SOPs, User manual, Test protocol, Traceability Matrix,• Summary Report and Compliance analysis, pre/post approving change requests.• Creating Validation plan, defining validation strategy and Risk analysis.• Involved in root cause analysis on process deviation.• Involved in preparation and review of test summary report.• Experience in review of SDLC deliverables like FS, TS, Configuration documents, CSV Risk Assessment, Test Protocol, Test Report, Pre/Post SIT scripts& Pre/Post UAT scripts in Jira and HP-ALM • Experience of test management tools using Jira, HP ALM, TFS• Experience in CR Review for CAB offline and online approval for SAP implementation projects.• Participate in CAB calls for CR online review.• Experience in handling COs in SOLMAN tool from Being Developed to Production for Non-GxP and GxP projects for SAP implementation projects.

Bengaluru Area, India

Bengaluru Area, India