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Pharmacovigilance & Safety > Postmarketed Pharmacovigilance Services

Postmarketed Pharmacovigilance Services

3,000+

Signalling reports delivered

300+

Molecules supported with aggregate reports

65+

Countries with aggregate report submissions

410K+

ICSRs processed annually

Comprehensive Postmarketing Pharmacovigilance for Global MAHs

Our end-to-end pharmacovigilance solutions are structured to maintain robust risk–benefit profiles and ensure timely regulatory submissions. We offer:

  • ICSR Case Intake & Processing – Accurate data capture, medical review, coding, and submission of post-marketing adverse events.
  • Expedited & Periodic Reporting – Timely submission of expedited reports in accordance with global regulatory timelines.
  • Signal Detection & Risk Evaluation – Continuous safety surveillance, signal management, and risk assessment activities.
  • Aggregate Report Writing – Preparation of PSURs, PBRERs, and other required safety documentation.
  • Global Regulatory Support – Oversight from experienced QPPVs and Local Safety Managers across 60+ countries.

With 24/7 operational support and inspection-ready quality systems, Soterius ensures seamless compliance with international pharmacovigilance standards.

Global Coverage, Local Regulatory Fluency

Soterius enhances post-marketing safety through innovative technology solutions that improve efficiency, transparency, and compliance. Our technology offerings support:

  • Automated workflows to streamline case processing
  • Real-time tracking and regulatory reporting dashboards
  • Data integration and system optimization
  • Advanced analytics for proactive safety oversight

By combining industry-leading expertise with intelligent, scalable technology, Soterius delivers customer-centric solutions that strengthen compliance, optimize operations, and improve patient outcomes.

Partner with Soterius for reliable, compliant, and technology-driven post-marketing pharmacovigilance services that evolve with your organization’s needs.

Clinical Safety Services

Why MAHs Choose Soterius

Global Submission Footprint

Aggregate reports submitted across 65+ countries with on-time calendar management.

Scale Without Quality Loss

3,000+ signalling reports delivered and aggregate reports for 300+ molecules.

Regulatory Fluency

Expertise in FDA 21 CFR 314, ICH E2E, EU-GVP, MHRA, PMDA, and Health Canada.

Physician-Led Medical Review

Safety physicians organized by therapeutic area.

Inspection-Ready Operations

90+ regulatory inspections supported, with PSMF maintenance and mock audit programs.

AI-Enabled Efficiency

UNITY™ platforms reduce manual effort while preserving human oversight.

Low Turnover

3.80% staff turnover rate ensures continuity of the team that knows your products.

Frequently Asked Questions

Postmarketed Pharmacovigilance Services

Speak With a US Medical Monitoring Expert

If you are conducting clinical trials in the United States and require FDA-aligned medical monitoring support, our team can help you strengthen safety oversight while maintaining regulatory confidence.