Our services
Pharmacovigilance
Safety, Structured. Oversight, Continuous.
We provide end-to-end pharmacovigilance capabilities spanning system establishment, operational safety activities, regulatory obligations, risk management, quality oversight and business continuity.
Capabilities
PHARMACOVIGILANCE
PV SYSTEM ESTABLISHMENT & GOVERNANCE
- PV System Design & Establishment
- PV System Gap Assessment
- PSMF Development & Maintenance
- PV SOP Framework
- Work Instructions & Forms
- PV Training
- PV Governance Framework
- PV Metrics & Management Reporting
QPPV & LOCAL PV OVERSIGHT
- QPPV Support
- LQPPV / Local Safety Officer Support
- Local PV Contact Management
- PV Oversight & Governance
- Regulatory Contact Management
- Escalation & Safety Governance
SAFETY INFORMATION MANAGEMENT
- Safety Intake
- ICSR Triage
- Case Processing
- Data Entry
- Medical Review
- Seriousness / Expectedness Assessment
- Causality Assessment
- Coding
- Narrative Development
- Follow-up
- Case Quality Review
- Duplicate Detection
- Reconciliation
SAFETY REPORTING
- Expedited Reporting
- Regulatory Submissions
- Follow-up Reporting
- Submission Tracking
- Compliance Monitoring
- Authority Correspondence
- Safety Database Reconciliation
LITERATURE & SURVEILLANCE
- Global Literature Surveillance
- Local Literature Monitoring
- Literature Monitoring
- Case Identification
- Article Assessment
- Medical Literature Review
- Emerging Safety Information
SIGNAL MANAGEMENT
- Signal Detection
- Signal Validation
- Signal Analysis
- Signal Evaluation
- Signal Management
- Emerging Safety Issue Assessment
- Benefit–Risk Evaluation
- Signal Documentation & Tracking
AGGREGATE REPORTING
- PSUR / PBRER
- PADER / Periodic Safety Reports
- DSUR
- ASR
- Line Listings
- Safety Tables
- Data Analysis
- Cumulative Review
- Benefit–Risk Evaluation
- Regulatory Submission Support
RISK MANAGEMENT
- Risk Management Plan (RMP)
- RMP Updates
- Important Identified / Potential Risks
- Missing Information
- Risk Minimisation Measures (RMM)
- Additional Risk Minimisation Measures
- Effectiveness Evaluation
- Risk Management Documentation
PV AGREEMENTS & THIRD-PARTY OVERSIGHT
- SDEA / PV Agreement Development
- Safety Data Exchange Requirements
- Responsibility Matrix
- Case Exchange Timelines
- Reconciliation Requirements
- Vendor / Partner PV Oversight
- Third-Party Compliance Monitoring
QUALITY & COMPLIANCE
- PV Quality Management System
- GVP Compliance Assessment
- GAP Assessment
- Internal / Vendor Audits
- CAPA
- Deviation Management
- Change Control
- Quality Metrics
- Compliance Monitoring
- Inspection Readiness
- Mock Inspection Support
BUSINESS CONTINUITY & CRISIS MANAGEMENT
- PV Business Continuity Planning
- Disaster Recovery Support
- Critical Process Identification
- Alternate Processing Arrangements
- Communication & Escalation Plans
- Business Continuity Testing
- Crisis Management Support
PV INTELLIGENCE & GOVERNANCE
- Regulatory Intelligence
- PV Compliance Tracking
- Safety Obligation Tracking
- Product / Territory Mapping
- Regulatory Commitment Tracking
- Management Review
- Periodic PV System Review
DIGITAL & TECHNOLOGY-ENABLED PV
- Safety Database Workflows
- Digital Case Tracking
- Literature Workflow Management
- PSMF Management
- Document Traceability
- Electronic Records
- Operational Dashboards
- Data Visibility & Reporting
Technology
Explore ViGenIQ →ViGenIQ™: Smart work. Without the Operational Burden.
ICSR Database, PSMF Manager and Literature Monitoring in one purpose-built PV platform, on a flexible subscription.
Discuss your pharmacovigilance requirements
Share your products, markets and current PV set-up, and we will outline the safety support you need.