Logesh Ramamoorthy

Background

About Logesh Ramamoorthy

Experienced PV Consultant with over 13 years in the pharmacovigilance domain, specializing in Japan reporting and case management. I bring deep expertise in implementing and managing PMDA-compliant periodic reports for mid-size and top-tier Japanese pharmaceutical companies. My work is rooted in ensuring operational excellence, regulatory compliance, and seamless execution of Japan-specific PV requirements. I have successfully led the implementation of multiple regulatory reports including NUPR, JPSR, Reexamination Reports, JDSUR, IPR, EPPV, and SLL. With a strong understanding of Japan’s E2B guidelines and PV frameworks, I have delivered high-impact solutions and resolved day-to-day operational issues with precision. Whether it's conducting client demos, managing cross-functional teams, or solving operational challenges, I strive to align pharmacovigilance strategy with client objectives while ensuring compliance and efficiency. Highlights : 13 years of hands-on experience in Pharmacovigilance and Drug Safety, with a sharp focus on Japan regulatory frameworks. Specialized in the end-to-end implementation of PMDA Periodic Reports such as: Non-Serious Unlisted Period Reports (NUPR 7-1, 7-2) Japan Periodic Safety Report (JPSR Form 3 & 4) Reexamination Reports (ReSD Forms 9, 10, 11, 13, 14) Japan Development Safety Update Report (JDSUR Form 1 & 2) Infection Periodic Reports (IPR Form 2, 4, 5) Early Post-Marketing Phase Vigilance (EPPV) Seiyakukyo Line Listing (SLL/JMPA) Strong command over Japan E2B reporting, case management workflows, and regulatory operations. Proven track record of identifying and resolving operational challenges, ensuring smooth and compliant PV processes. Experience delivering product demos and guiding clients through PV system capabilities and implementations. Core Competencies : PMDA Report Regulations & Implementation Japan Case Management & E2B Reporting Pharmacovigilance & Drug Safety Systems Product Management Strategic Business Planning Business Analysis & Consulting Agile Frameworks & Delivery Customer Relationship Management Engagement Leadership & People Development