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Postmarketed Pharmacovigilance Services > Case Intake, Processing, Submissions, & Medical Review

Overview Technology Offerings for Safety & Medical Information

At Soterius, we deliver comprehensive technology solutions that power efficient,compliant, and data-driven Safety and Medical Information operations. By combining pharmacovigilance expertise with advanced digital innovation, we help organizations streamline workflows, enhance visibility, and maintain regulatory readiness across the entire product lifecycle. Our scalable, secure systems are designed to support global pharmaceutical and biotechnology companies in an increasingly complex regulatory environment.

Expertise-Driven Innovation

Our technology solutions are backed by experienced safety professionals, QPPVs, and Medical Information specialists who understand global regulatory requirements and operational challenges. With 24/7 support, inspection-ready quality systems, and a commitment to continuous improvement, Soterius delivers technology-enabled services that strengthen compliance, optimize performance, and ultimately improve patient outcomes.

Partner with Soterius to modernize your Safety and Medical Information operations with intelligent, scalable, and future-ready technology solutions.

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Technology Solutions for Pharmacovigilance & Safety
Our safety-focused technology offerings strengthen operational control and regulatory compliance through intelligent system design and optimization, including:

  • Safety Database Implementation & Optimization – Configuration, migration,
    validation, and lifecycle management of global safety databases.
  • Automated Case Processing Workflows – Workflow automation that enhances data accuracy, accelerates case processing, and reduces manual burden.
  • Regulatory Reporting & Compliance Monitoring Tools – Real-time dashboards to track submission timelines, health authority commitments, and global compliance metrics.
  • Signal Detection & Advanced Analytics – Data-driven tools to support proactive risk identification and benefit–risk evaluation.
  • Inspection Readiness & Quality Management Systems– Integrated tools that ensure continuous audit preparedness and documentation control.

These solutions provide enhanced transparency, operational efficiency, and full oversight of safety activities.

Medical Information Technology Enablement
Soterius also supports Medical Information functions with technology-driven platforms that improve responsiveness, consistency, and knowledge management. Our offerings include:

  • Medical Information Management Systems – Centralized platforms for tracking, documenting, and responding to medical inquiries efficiently.
  • Content & Knowledge Management Solutions – Structured repositories that ensure accurate, up-to-date scientific responses.
  • Workflow Automation & Case Tracking – Digital tools that streamline inquiry handling and improve turnaround times.
  • Data Integration & Reporting Tools – Advanced analytics and reporting capabilities to generate actionable insights and performance metrics.

By integrating Safety and Medical Information systems, Soterius enables seamless data
exchange, improved collaboration, and enhanced decision-making across functions.

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