SeltaSquare

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Combining hands-on PV operational experience with an AI-based platform to advance safety data management

 

SeltaSquare has appointed Jeong-min Lee as the Head of its Pharmacovigilance (PV) services. The move is part of the company's strategy to strengthen safety data management and global electronic reporting capabilities for pharmaceutical and biotech companies by combining hands-on PV operational experience with its AI-based platform.

SeltaSquare (CEO: Min-kyung Shin), a life science data company, announced the appointment of Jeong-min Lee as the overall head of its PV services. Lee is a pharmaceutical expert with over 15 years of domestic and international PV experience, having previously served as Executive Vice President at LSK Global PS, where she oversaw the Data & Safety division.

Pharmacovigilance refers to the system of collecting, evaluating, and reporting adverse event information from the drug development stage through post-approval, and managing drug safety on that basis. PV work has recently expanded beyond clinical trial safety reporting to include post-market adverse events, literature information, submissions to global regulatory authorities, and real-world data (RWD) analysis. In particular, as the adoption of ICH E2B(R3) — the electronic transmission standard for Individual Case Safety Reports (ICSRs) — has grown, PV competitiveness is increasingly determined not by reporting speed alone, but by data standardization and quality management capabilities.

SeltaSquare is driving the digital transformation of PV operations centered on its AI-based PV platform, iVigilance Square. Through this platform, the company supports a full range of PV functions, including safety database management, literature monitoring, E2B R3 electronic reporting conversion, safety data aggregation, medical evaluation, and MedDRA coding.

AI and digital technologies are considered to have strong potential in repetitive data processing and standardization tasks within PV — such as literature monitoring, adverse event candidate screening, ICSR data structuring, MedDRA coding, E2B(R3) XML conversion, and report quality review. However, areas such as medical causality assessment, expectedness determination, and seriousness judgment (including serious adverse event [SAE] classification) still require expert review.

This appointment is aimed at integrating real-world operational experience into the platform-centered PV service model. With Lee on board, SeltaSquare plans to refine its CRO operational framework and incorporate regulatory submission requirements, client standard operating procedures (SOPs), and global study management experience into platform development and service delivery.

Lee has experience building and managing pre- and post-market PV specialist departments within Korea's CRO industry. She has served as EudraVigilance Responsible Person (RP), supporting global study setup, and has led numerous projects involving the implementation and operation of global safety databases including Oracle Argus and ArisGlobal.

As Korean pharmaceutical and biotech companies expand their clinical trials and regulatory approvals in the US and Europe, PV operations are shifting from domestic reporting to a focus on global electronic reporting and audit readiness. Experience with safety databases such as Oracle Argus and ArisGlobal — covering adverse event intake, deduplication, MedDRA coding, medical review, electronic reporting, and submission history management — is recognized as a core capability for global PV compliance.

Lee has also completed advanced training programs from major institutions, including DIA's Advanced Pharmacovigilance Auditing and Pharmacovigilance and Risk Management Strategies, EMA's EudraVigilance Training, and Japan's PMDA Risk Management Plan Training.

Industry observers note that for AI-based PV services to gain broader adoption, they must ensure not only technical performance but also verifiability, audit traceability, and data integrity. Since PV is subject to both regulatory inspections and client audits, automated outputs must be explainable in terms of the standards and procedures by which they were generated. For now, the consensus is that AI platforms are more likely to establish themselves as operational infrastructure that enhances reporting quality and efficiency, rather than replacing expert judgment.

Lee commented: "I will contribute to building a trustworthy safety data management system for pharmaceutical and biotech companies by combining AI-based PV platform capabilities with pharmacovigilance operational expertise. I also look forward to contributing to the advancement of iVigilance Square from the perspective of a hands-on practitioner."

CEO Min-kyung Shin said: "With Jeong-min Lee joining us, our PV service operational expertise and global response capabilities will be significantly strengthened. We will expand our service capacity to connect safety data all the way through to RWD-based insights."

Original Artical: https://www.yakup.com/news/index.html?mode=view&cat=12&nid=327804