Pavan Kumar Reddy

About Pavan Kumar Reddy

Dedicated professional with extensive expertise in Pharmacovigilance and Regulatory…

Experience

1. Business Process Lead in Global Pharmacovigilance Aggrement Management

   Tata Consultancy Services

   Jun 2024 — Present · Thane, IN

   Monitoring compliance of PV agreements, including compliance checks and reconciliation of human safety information from various sources (spontaneous, solicited, post-marketing reports) in accordance with PV obligations. Proficient in managing PSMF annex B4 for major contractual agreements, configuring Argus reporting rules for new/amended/revised PV agreements, and ensuring all activities are performed once agreements become effective. Expertise in automating Outlook for shared mailboxes, saving hours weekly, and handling mailbox management. Skilled in tracking upcoming audits/inspections, notifying third parties of upcoming regulatory inspections, and maintaining documentation for future compliance checks. Strong negotiation skills with internal and external stakeholders, providing vendor training for new processes, and tracking CAPA from VQMS. Responsible for dispatching aggregate reports (Label, DSUR, PBRER, RMP, etc.) to third parties per PV agreement clauses, creating tip sheets for internal processes, and developing new databases for PV agreements, including training material preparation and delivery.