Niteen Pawar

Experience

1. Senior Pv Safety Analyst

   Tata Consultancy Services

   Jul 2023 — Present · Pune, IN

   SME for end to end PV activities involving ICRS intake to submission along with all types of reconciliation activities.Led end-to-end reconciliation of Individual Case Safety Reports (ICSRs) between global safety databases (e.g, Argus) and partner/vendor systems to ensure regulatory compliance and data integrity.Acted as a liaison between internal PV teams, CROs, Regulatory Affairs, and Clinical Operations for safety data alignment and discrepancy resolution.Coordinated with global stakeholders to establish reconciliation schedules, documented discrepancies, and ensured timely resolution in line with SOPs and Health Authority guidelines (e.g, FDA, EMA).Prepared reconciliation reports, tracked KPIs, and supported internal/external audits and inspections with reconciled data summaries.Participated in the development and maintenance of reconciliation SOPs and Work Instructions, and trained new team members on reconciliation best practices.Supported signal management and aggregate reporting by ensuring accuracy and completeness of reconciled safety data.Specially have hands on Reconciliation activities with third party exchange.

Skills

• Strategic Communications
• Clinical Research
• Microsoft Powerpoint
• Clinical Research Associates
• Team Management
• Pharmacovigilance
• Ms Office
• Clinical Data Management
• Clinical Trials
• Team Spirit
• CRO Management
• Microsoft Excel
• Pharmacy
• English Grammar