Ennov PV Risk Management

Execution-Driven Risk Management with Global Coordination & Performance Visibility

Ennov PV Risk Management provides a centralized, compliant, and execution-focused platform for managing product safety risks across the full product lifecycle. Moving beyond static documentation, the solution enables organizations to plan, execute, track, and measure risk management activities globally and locally with full transparency. 

  • Accurately capture and manage both human and veterinary PV cases
  • Import adverse event data or enter directly using flexible templates
  • Fully configurable workflows to support end-to-end case processing
  • Seamlessly integrates into existing pharmacovigilance operations
  • Trusted by pharma, CROs, service providers, and regulators
  • Scalable, compliant, and designed to fit your business processes

Integrated Global RMP Management & Local Assessment Execution 

Ennov seamlessly connects global risk management strategy with local regulatory execution, ensuring alignment, traceability, and timely implementation: 

  • Unified RMP governance 
    + Create, author, review, approve, and version-control global and local RMPs 
    + Maintain parent-child relationships between core and affiliate RMPs 
    + Manage country-specific deviations, commitments, and annexes 
    + Support multilingual content and localization workflows 
  • Local assessment & implementation 
    + Assess impact of global safety updates on local markets 
    + Evaluate labeling changes and regulatory requirements 
    + Document medical and regulatory justifications 
    + Track approvals, escalations, and completion status 
  •  Process, tracking & notifications 
    + Configurable workflows for authoring, review, approval, and updates 
    + Automated task assignment with clear ownership and deadlines 
    + Real-time status tracking across global and affiliate teams
    + Automatic notifications for required local assessments and overdue tasks and escalations 

Integrated Risk Minimization (aRMM) & PV Activities (aPVP) Management

Ennov provides a unified framework to manage, execute, and monitor all risk minimization measures and pharmacovigilance commitments.

  • End-to-end activity management

    + Manage a RMMs:     Educational materials, Controlled access programs, Safety communications (HCP/patient)

    + Manage aPVPs: PASS studies and registries, Targeted follow-up activities, Enhanced monitoring and signal follow-up

    + Link all activities to:     Safety concerns and RMP elements, Regulatory commitments and milestones, Supporting documentation and deliverables  
     
  • Execution tracking & task management  

    + Define milestones, deliverables, and timelines 
    + Assign tasks with ownership and accountability 
    + Monitor progress, completion status, and dependencies 
    + Ensure full traceability of all actions and updates 

  • Notifications & compliance control 

    + Automated alerts for:     Upcoming milestones, Delays or overdue tasks, Required approvals or actions  

    + Escalation workflows to ensure on-time execution 
    + Controlled distribution and tracking of risk minimization materials 

Analytics, KPIs & Performance Monitoring

Ennov provides real-time analytics and KPI dashboards to deliver full visibility into risk management performance and compliance.

  • Operational dashboards  
    + Overview of RMP status across products and regions 

    + Tracking of local assessment progress and completion rates 
    + Visibility into aRMM and aPVP execution status 

  • Key performance indicators (KPIs) 

    + Timeliness of local assessments and approvals 
    + Adherence to regulatory commitments and deadlines 
    + Completion rates of risk minimization activities 
    + Distribution and acknowledgment metrics for aRMMs 
    + Study and activity milestone performance (aPVPs) 

  • Advanced performance insights   
    + Identification of bottlenecks and process delays 
    + Trend analysis across regions, products, and activities 

    + Support for continuous improvement and inspection readiness 

  • Reporting & audit readiness  
    + Generate inspection-ready reports and evidence 
    + Full traceability of decisions, actions, and outcomes 

    + Alignment with global regulatory expectations (GVP, FDA, EMA) 

Business Benefits

By implementing Ennov PV Risk Management, organizations can:

Ennov PV Risk Management transforms risk management from a document-centric process into a structured, collaborative, and data-driven operational framework that improves global oversight, reduces compliance risk, and accelerates execution of pharmacovigilance obligations. 

  • Improve compliance with global and local RMP requirements
  • Reduce compliance risk through automated tracking of obligations and deadlines
  • Increase efficiency by replacing manual processes with standardized workflows
  • Strengthen global and local collaboration on risk management activities
  • Enhance visibility into RMP status, aRMMs, aPVPs, and local assessments
  • Improve traceability and inspection readiness with complete audit trails
  • Accelerate implementation of risk minimization and safety activities
  • Enable more proactive and effective product risk management

Core Capabilities

  • Optimized case capture interface
  • Search engine style querying
  • Configurable data section and field layouts
  • Searchable vocabulary lists
  • Rapid coding tool
  • Drag-and-drop palette for frequently used data
  • Speech to text for narratives
  • Social style case management tools

Key Features

  • Data entry interface is configured to mirror call flow
  • Dramatically speeds up data entry
  • Modern and intuitive layout
  • Optimized for call center operations
  • Reduces training overhead and accelerates on-boarding
  • Seamless connectivity to PV-Works
  • 100% web-based
  • 21 CFR Part 11 compliant

How a Global Pharma and Animal Health Leader Migrated 1M+ Safety Records to the Cloud

When infrastructure modernization meets zero tolerance for downtime

Read The Case Study

From Vendor Frustration to Compliance Confidence

How a Human Pharmacovigilance Services Provider Found a Long-Term Platform and Partner

Read The Case Study

An End-To-End Solution for Collecting, Reporting and Analyzing Human and Vet PV Data 

The Ennov Pharmacovigilance solution keep the collection, management, assessment, and reporting of human or veterinary adverse events in one unified database while also providing advanced signal detection and PV data analysis tools.

Explore the PV Suite

Why Choose Ennov

Over 500,000 users trust Ennov

  • Over 25 years of experience providing software solutions for Life Sciences and 450+ Life Science customers, with many more in other industries.
  • Modern architecture and interface 100% web-based. Highly scalable. User-centric design.
  • Our commitment to your success Very high customer satisfaction, 98.5% of projects delivered on time and within budget.

Providing you freedom of choice

  • Available as cloud-based or on-premises deployment, you can switch between deployment options at any time.
  • System configuration and management require no IT skills, making you fully autonomous
  • Improved security and optimized performance. Data can be hosted locally for total flexibility. Single-tenancy minimizes business interruptions.

Cloud-based or On Premises

Multi-Platform

ISO 9001 & 27001 Certified

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