Ennov
Pharmacovigilance Software Suite
End-to-End Pharmacovigilance Software for Global Safety Operations
Modern pharmacovigilance organizations need pharmacovigilance software that helps them detect safety risks earlier, manage increasing adverse event volumes, maintain regulatory compliance, and demonstrate inspection readiness across global operations.
Many organizations still rely on disconnected systems, manual processes, fragmented safety data, and limited visibility across critical pharmacovigilance activities.
The Ennov Pharmacovigilance Software Suite provides a fully integrated platform for managing the complete pharmacovigilance lifecycle—from adverse event case processing and signal detection to risk management, safety agreements, document management, and executive reporting.
Built on the unified Ennov platform, the suite enables pharmaceutical, biotechnology, medical device, consumer health, and veterinary organizations to streamline safety operations, improve compliance, and gain complete visibility into product safety across the enterprise.
Pharmacovigilance software helps life sciences organizations manage drug safety data, adverse event cases, signals, risks, regulatory reporting, safety documentation, and compliance activities throughout the product lifecycle.
A modern pharmacovigilance platform brings these processes together in a controlled environment, helping safety teams improve data consistency, workflow traceability, reporting compliance, and inspection readiness.
Ennov extends this approach across case management, signal management, safety documents, risk management, pharmacovigilance agreements, and safety analytics.
Unlike standalone safety applications that create data silos, Ennov delivers a connected pharmacovigilance environment where information flows seamlessly across safety, regulatory, quality, and clinical functions.
The Ennov PV Suite includes:
- Ennov PV Case Management
- Ennov PV Signal Detection & Signal Management
- Ennov PV Safety Documents
- Ennov PV Risk Management
- Ennov PV Agreements
- Ennov PV Dashboard
Together, these solutions provide a single authoritative source for pharmacovigilance operations while supporting global regulatory requirements and inspection readiness.
How a Global Pharma and Animal Health Leader Migrated 1M+ Safety Records to the Cloud
When infrastructure modernization meets zero tolerance for downtime
From Vendor Frustration to Compliance Confidence
How a Human Pharmacovigilance Services Provider Found a Long-Term Platform and Partner
- Multi-channel case intake
- ICSR processing and lifecycle management
- MedDRA, VeDDRA and WHO Drug coding
- Medical review and quality control workflows
- E2B(R3) reporting
- Regulatory submission management
- Follow-up management
- Case reconciliation
- Global and local compliance tracking
By automating safety case workflows and regulatory reporting activities, organizations can improve case quality, reduce manual effort, and meet reporting timelines with confidence.
Ennov PV Case Management
Streamline Adverse Event Processing and Regulatory Reporting
Ennov PV Case Management supports the complete lifecycle of adverse event and ICSR processing within the broader Ennov pharmacovigilance software platform.
Organizations can capture, assess, review, approve, follow up, lock, and report safety cases through controlled workflows designed to support global pharmacovigilance requirements.
Key capabilities include:
- Statistical disproportionality analysis
- Signal detection and prioritization
- Signal validation and assessment
- Qualitative and quantitative evaluations
- Review and approval workflows
- Risk classification and documentation
- Signal history and traceability
- Integrated signal reporting
Ennov’s pharmacovigilance signal management software supports proactive safety surveillance while maintaining clear documentation and regulatory oversight.
Key capabilities include:
Ennov PV Signal Detection & Management
Identify, Evaluate, and Manage Emerging Safety Risks
Ennov PV Signal Detection & Management provides a structured framework for detecting, evaluating, prioritizing, and managing potential safety signals.
The solution combines statistical signal detection with controlled assessment and governance workflows, helping pharmacovigilance teams document decisions and maintain traceability throughout the signal lifecycle.
- Pharmacovigilance System Master Files (PSMFs)
- Literature Monitoring, Data output
- Safety, Periodic and Aggregate Reports
- Risk & Signal Documentation
- Training and Brochure Materials
- Quality & Compliance
- Safety Notification Distribution
Advanced workflows, version control, electronic signatures, and audit trails help ensure pharmacovigilance documentation remains controlled, traceable, and ready for regulatory inspection.
Ennov PV Safety Documents
Maintain Continuous Inspection Readiness
Ennov PV Safety Documents provides a centralized environment for managing controlled pharmacovigilance documentation and compliance records.
As part of the Ennov Pharmacovigilance Software Suite, the solution helps teams maintain current, approved, and inspection-ready safety documentation across global operations.
Organizations can manage:
Ennov PV Risk Management
Manage Core Company and Local Risk Management Plans
Ennov PV Risk Management supports the complete lifecycle of pharmacovigilance risk management activities, from planning and assessment to implementation, tracking, and effectiveness evaluation.
The solution helps organizations manage global and local risk obligations within a controlled and traceable environment.
Key capabilities include:
- Core and EU / local Risk Management Plans (RMPs)
- Local impact assessment processes
- Additional Risk Minimization Measures (aRMMs)
- Additional Pharmacovigilance Activities (aPVPs)
- Risk mitigation tracking
- Regulatory commitment management
- Effectiveness evaluations
- Inspection-ready reporting
Ennov’s pharmacovigilance risk management capabilities help teams maintain visibility into safety commitments while supporting consistent execution across regions and affiliates.
Ennov PV Agreements
Control Safety Agreements and Third-Party Safety Obligations
Managing pharmacovigilance agreements across global partner networks often creates administrative complexity and compliance risk.
Ennov PV Agreements extends the pharmacovigilance software platform to third-party safety obligations, providing a centralized environment for managing agreements, responsibilities, renewals, and compliance activities.
Capabilities include:
- Pharmacovigilance Agreement (PVA) management
- Safety Data Exchange Agreement (SDEA) management
- Partners, Vendors and Contact management
- Safety Obligation and Responsibility tracking
- Compliance monitoring
- Agreement Renewal and expiration management
- Workflow automation
- Full audit trail and traceability
Organizations gain clearer visibility into third-party responsibilities while reducing the risk of missed commitments and unmanaged safety obligations.
- Case processing performance
- Regulatory compliance metrics
- Signal management activities
- Risk management obligations
- Agreement compliance
- PSMF and document status
- Affiliate performance
- Inspection readiness indicators
Role-based dashboards give pharmacovigilance teams a clearer view of operational performance and emerging risks across the organization.
Ennov PV Dashboard
Transform Safety Data into Actionable Insights
Ennov PV Dashboard provides real-time visibility across the Ennov pharmacovigilance software ecosystem.
Interactive dashboards and reporting capabilities help safety leaders monitor performance, identify compliance risks, and maintain oversight across global pharmacovigilance operations.
Interactive dashboards and advanced reporting capabilities enable organizations to monitor:
One Platform. Complete Visibility.
Because all Ennov pharmacovigilance applications are built on a common platform, organizations benefit from:
- A single source of truth for safety data
- Seamless cross-functional workflows
- Reduced data duplication
- Improved collaboration
- Consistent user experience
- Simplified validation and administration
- Enhanced compliance oversight
The result is a more connected, efficient, and compliant pharmacovigilance organization.
Key Benefits of the Ennov Pharmacovigilance Software Suite
Modern Pharmacovigilance for a Complex Regulatory Environment
As safety requirements continue to evolve, organizations need more than standalone applications—they need a connected platform that supports the entire pharmacovigilance lifecycle.
The Ennov Pharmacovigilance Software Suite empowers life sciences organizations to manage safety operations more efficiently, maintain compliance with confidence, and protect patients through proactive, data-driven pharmacovigilance.
- Improve patient safety through proactive safety surveillance
- Accelerate adverse event processing and reporting
- Strengthen regulatory compliance globally
- Maintain continuous inspection readiness
- Streamline signal detection and risk management
- Improve oversight of partners and third parties
- Reduce manual processes and administrative burden
- Increase operational efficiency across safety teams
- Gain real-time visibility into safety performance
- Support scalable growth with a unified platform
Pharmacovigilance Software FAQs
What is pharmacovigilance software?
Pharmacovigilance software is a drug safety system used to manage safety data and PV processes across a product’s lifecycle. It helps teams capture and process cases, maintain compliant records, support reporting timelines, and monitor safety trends with consistent workflows and traceability.
What is pharmacovigilance software used for?
Pharmacovigilance software is used to support end-to-end PV operations, including case intake and triage, coding, medical review, submissions and reporting, signal detection and management, and ongoing safety oversight. It helps PV teams reduce manual work, maintain data quality, and stay inspection-ready across global operations.
What is ICSR case management, and how does pharmacovigilance software support it?
ICSR (Individual Case Safety Report) case management covers the process of capturing adverse event information, assessing seriousness and expectedness, coding relevant terms, performing medical review, and maintaining a complete case history. Pharmacovigilance software supports this by standardizing intake, routing tasks for review and QC, preserving audit trails, and enabling efficient follow-up and reporting.
What is case intake in pharmacovigilance?
Case intake is the process of receiving potential safety information from sources such as spontaneous reports, literature, clinical programs, partners, or medical information channels. Pharmacovigilance software helps by structuring intake, capturing the required minimum information, supporting deduplication and triage, and routing cases into the right workflow for assessment.
What is expedited reporting in pharmacovigilance?
Expedited reporting refers to time-sensitive reporting requirements for specific case types, typically based on seriousness, expectedness, and timelines defined by regulations and SOPs. Pharmacovigilance software helps teams manage expedited reporting by tracking deadlines, supporting workflows for review and QC, and maintaining consistent case documentation for inspection readiness.
What is signal detection in pharmacovigilance, and what role does software play?
Signal detection is the process of identifying potential new safety concerns by reviewing trends and patterns across safety data sources. Pharmacovigilance software supports signal detection by consolidating safety data, enabling structured review and documentation of signal evaluation steps, and supporting governance around decisions, actions, and follow-up.
What is a PSMF in pharmacovigilance, and how can software help?
A PSMF (Pharmacovigilance System Master File) describes how a company’s PV system is organized, including processes, responsibilities, and supporting documentation. Pharmacovigilance software can help by maintaining controlled, inspection-ready PV documentation, ensuring consistency across updates, and supporting traceability of approvals and revisions.
What is a QPPV, and why does a PV system matter?
The QPPV (Qualified Person Responsible for Pharmacovigilance) role is responsible for oversight of the PV system and ensuring it operates effectively. A PV system matters because it provides visibility, governance, and documentation needed to demonstrate oversight, compliance, and control across PV activities and safety documentation.
What is the difference between pharmacovigilance software and drug safety software?
In practice, the terms are often used interchangeably. “Drug safety software” usually refers to the technology supporting PV processes, while “pharmacovigilance software” may emphasize regulatory and lifecycle safety obligations. The important evaluation point is whether the platform supports your required PV workflows, documentation, and compliance needs across the lifecycle.
What pharmacovigilance processes does Ennov support?
Ennov supports the full pharmacovigilance lifecycle, including case intake and management, signal detection and management, risk management activities, regulatory reporting support, and PV quality and governance processes. Ennov also supports PV documentation management, helping teams keep PSMF, procedures, agreements, and safety documentation organized, controlled, and inspection-ready.
How does Ennov support pharmacovigilance documentation management?
In addition to pharmacovigilance workflows, Ennov includes Doc for PV to manage PV-related documentation such as PSMF content, procedures, safety agreements, reports, and supporting evidence. It helps teams maintain controlled documents with traceability, version control, and consistent access across PV stakeholders.
Does Ennov support pharmacovigilance for human and veterinary products?
Yes. Ennov’s pharmacovigilance software is designed to support PV operations for both human and veterinary products, with configurable workflows and documentation controls to align with your organization’s processes and regulatory obligations.
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