Vermilan Bal

Work Experience in CSV: around 2 years

• Role: Computer System Validation (CSV) Lead-
• Support all CSV activities at multiple sites and ensure procedural consistency
• Manage tasks, schedules, and deliverables associated with overall related to laboratory, manufacturing, engineering, and enterprise Systems
• Create, review, and/or approve all CSV validation plans, change requests, upgrade release assessment, user requirements (URS), release notes, role matrix, UAT test protocol, UAT test case, review of executed UATs and routing IQ, requirements traceability matrix (RTM), validation reports, SOPs
• Build and maintain trusting, collaborative relationships and partnerships with internal stakeholders to ensure key business objectives are achieved

Work Experience in end to end Pharmacovigilance: around 5.5years

Role: Quality Assurance & Quality team management-

• Responsible for oversight of day to day productivity tracking and reporting; trains and coordinates with team members to ensure compliance with completion and accuracy
• Generating quality control reports and reporting of Quality metrics to stakeholders
• Track correction of defective cases
• Escalate identified patterns/trends and major/critical findings to GPV GCM training and compliance team and service management team
• Act as member in service management team meeting and if required in Steering Committee meetings

Role: Quality Reviewer-

• End to end Quality Review of ICSR’s for PV process.
• Ensure compliance of operations with governing regulatory requirements. Assist in addressing periodic client quality reviews and other ad-hoc client quality findings.
• Assist Manager in identifying quality trends and conduct of process review coordination to develop process standards for measurements and process improvements.
• Support in initiating discussion forums on Quality errors within assigned project and identify process improvements, share best practices across teams

Role: Data Entry-

• End to end data entry of ICSR’s, Narrative writing, labelling assessment and SUSAR identification
• Duplicate search, logical Deletion, Inactivation of ICSR’s
• Prioritization of cases based on internal and external timelines
• Prioritization of cases based on seriousness, listedness, internal and partner timeline