Scalable case processing across the lifecycle.

Our PV operations team delivers seamless, compliant, and scalable safety case handling across the product lifecycle - from clinical development through post-marketing surveillance.

Whether managing a single product or a global portfolio, our systems and teams scale to meet evolving volume, complexity, and geographic needs. We are fluent in leading safety systems, including Oracle Safety One, Argus J, IRMS, and document tracking platforms, ensuring traceability, automation, and audit readiness.

Core Services
  • Case Management: End-to-end processing of safety cases
  • Named Patient Programs (NPP): Safety oversight for patients outside clinical trials
  • Expanded Access Programs (EAP): Pre-approval access support ensuring compliance and patient safety
  • Compassionate Use & Post-Marketing: Management of reports from real-world use
  • Reporting & Submission: Timely, accurate submissions to global health authorities
Safety Systems Management
  • Configuration, validation, and maintenance of safety databases
  • Oracle Safety One & Argus J: End-to-end case processing, workflow automation, and regulatory reporting
  • Document Distribution & Tracking: Secure, auditable systems for distributing safety documents
Local Literature Search
  • Country-specific literature reviews in local languages
  • Identification of reportable adverse events and emerging safety signals
  • Alignment with national authority expectations
  • Coordination for timely case processing and reporting

Key PV Roles

QPPV (Qualified Person for Pharmacovigilance)
  • Overall PV system oversight
  • Compliance with EU PV regulations
  • Signal detection, risk management, and regulatory communication
  • 24/7 availability for urgent safety issues
  • Must reside in the EU/EEA
LCPPV (Local Contact Person for Pharmacovigilance)
  • Acts as local liaison with national health authority
  • Ensures timely local case reporting
  • Supports local literature screening
  • Implements global PV processes locally
  • Must reside in the country of operation
Local Safety Officer (LSO)
  • Handles operational PV tasks at local level
  • Collects and forwards adverse event reports
  • Maintains inspection readiness
  • Supports audits and compliance monitoring
  • Typically local presence, less formal than LCPPV