Solutions and Services | Pharmaco-Vigilance & Safety

Case & Document Management, Literature Screening and Reporting

Contact us now to receive further information and an assessment from our experts. We will work with you to evaluate the best approach for your business processes.

Arithmos – End-to-End Vigilance Operations for Case Management and Reporting Excellence

Navigating the Complexities of Global Pharmacovigilance

In today’s tightly regulated environment, life sciences companies are expected to manage safety data and documentation in real time, across markets, systems, and partners. Compliance with regulatory guidelines requires integrated processes for Individual Case Safety Report (ICSR) handling, literature screening, and timely submission of periodic safety reports.

Organizations must now embrace digital, quality-centric workflows to ensure compliance, streamline operations, and proactively detect and mitigate product risks.

Arithmos’ Integrated Vision

At Arithmos, we believe case management and reporting are more than regulatory obligations—they are key levers for risk minimization, market confidence, and patient trust. Our integrated model—rooted in deep pharmacovigilance knowledge and powered by enabling technology—delivers agile, compliant, and future-ready safety operations.

We support you across the full pharmacovigilance lifecycle, ensuring consistency, compliance, and scalability across markets.

Our Unique Value Proposition

  • Consulting: Design and optimization of end-to-end case management processes, literature workflows, and reporting strategy
  • Technology: Integration of AI/RPA for screening, processing, and reporting
  • Services: Scalable FSP models (inshore, nearshore, offshore), QPPV function, LQPPV support, and talent acquisition via our Incubator Model

Consulting

  • PV system, processes and organization evaluation / reorg including new technologies enhancements (Cloud, AI, RPA)
  • PV/Safety reporting design and optimization

Technology

  • Safety System, PSMF solutions, Safety data analytics solutions:
  • Design, implementation, integration (Technology agnostic approach; experience with Veeva, Oracle, ArisG, Agatha, SharePoint among others.)
  • Data migration (included “Move to Cloud”), Data Warehousing and standardization
  • Validation, with focus on User Requirements definition and System Testing
  • Enhancements by AI/ML tools (Periodic Reporting, Signal Detection, Compliance Reporting)
  • Pharmacovigilance and Safety Process automation (RPA)

Services

  • Medical expertise (Physicians, QPPV and Certified Eudravigilance team, FDA)
  • Enhanced Technology Case Processing and Reporting
  • Enhanced Technology Literature Screening
  • FSP model team augmentation (Inshore, Nearshore and/or Offshore Delivery model)
  • Talent acquisition via Incubator model
  • QPPV Role /QPPV deputy Function Delegation
  • LQPPVs coverage

Get an assessment

Let’s work together to address the challenges in pharmacovigilance and ensure the safety of patients worldwide. Contact us to explore how our services can solve your pharmacovigilance needs.