Abdul Kalam Email and Phone Number

• Lead and organize safety processes to ensure timely project completion.• Manage the allocation and supervision of team tasks, ensuring adherence to project timelines and budgets.• Track and manage project risks and issues related to safety and pharmacovigilance.• Ensure compliance with regulatory standards and SOPs while preparing expedited safety reports.• Support safety database management, including coding, validation, and reconciliation of ICSR data.• Perform quality control activities, peer reviews, and validation of data for regulatory submissions.

• Acted as Subject Matter Expert (SME) in SPVG, providing coaching and guidance on safety data processing.• Supervised a team to ensure timely submission of individual and periodic safety reports.• Led quality reviews of safety databases to ensure completeness, accuracy, and consistency of data.• Managed workflows for ICSR processing, including triaging, coding, and narrative writing.• Conducted audits and inspections to meet regulatory requirements.

• Managed data entry and peer reviews for adverse event reports in the ArisG safety database.• Conducted follow-ups on adverse event reports, ensuring compliance with internal SOPs and timelines.• Performed UAT testing, creating and executing test cases and scripts to ensure smooth database migration.• Worked with internal staff to resolve issues and improve team performance on safety data quality.