Arithmos – Enabling Smart Pharmacovigilance Through Safety Systems, PSMF Excellence, and Integrated Analytics 

Technology as a Strategic Foundation — Domain Expertise as the Driver

In pharmacovigilance today, regulatory compliance is a baseline requirement. Safety systems must be validated, scalable, and seamlessly integrated. The PSMF requires ongoing management to accurately reflect operational processes, while analytics must deliver clear, actionable insights rather than raw data. Regulatory frameworks such as GVP Modules I, II, and VII require Marketing Authorization Holders and Sponsors to maintain rigorous control over data and systems.

Arithmos’ Connected Safety Operations Model

Our approach blends deep pharmacovigilance domain expertise with advanced technology skills to build a truly integrated and insight-driven safety ecosystem. Our team ensures it remains inspection-ready and aligned with evolving clinical trial and post-marketing requirements worldwide.

Technology enables streamlined updates, full traceability, and seamless linkage of source systems—including Safety Databases and CTMS platforms—to facilitate smooth data flow. The strength of our model lies in the synergy between operational knowledge and technical capabilities, addressing the complex interdependencies across the PV network.

By integrating validated Safety DBs, dynamic PSMF management, and structured analytics platforms, we deliver more than regulatory compliance—we enable smarter, faster, and safer pharmacovigilance decisions. Our holistic approach reduces manual workload, improves inspection readiness, and enhances governance throughout safety operations.

Our Unique Value Proposition

• Consulting: Strategic definition of PV architecture, PSMF structuring, and analytics objectives
• Technology: Platform-agnostic DB and analytics solutions with full validation lifecycle
• Services: Maintenance of validated DBs and PSMFs, integrated analytics deployment, signal detection and periodic reporting