Ennov PV Agreements

End-to-End Contract, Data & Responsibility Governance

Ennov PV Agreements provides a centralized, compliant, and execution-driven platform to manage pharmacovigilance agreements, third-party relationships, and safety obligations across global partner networks. The solution goes beyond document storage by enabling organizations to manage agreement lifecycles, master data, operational responsibilities, and performance tracking in a fully integrated environment. 

  • 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

Centralized Master & Operational Agreement Management 

Ennov enables full control over the lifecycle of safety agreements, from authoring through execution, renewal, and audit: 

Comprehensive agreement management 

  • Manage all agreement types, including:  
    + Master Service Agreements (MSAs)  
    + Pharmacovigilance Agreements (PVAs) 
    + Safety Data Exchange Agreements (SDEAs) 
    + Vendor, CRO, distributor, and partner agreements 
    + Link master agreements (e.g., MSA) to operational PV and vendor agreements 
  • Lifecycle, process & document automation  
    + Support authoring, review, approval, and electronic signature workflows for internal and external approvers 
    + Centralized repository for secure storage and version control 
    + Track effective dates, renewals, expirations, and amendments 
    + Automated document generation using standardized templates and harmonized vocabularies 
  •  Tracking & notifications 
    + Automated alerts for: Upcoming renewals and expirations, Pending approvals and signatures, Contract changes impacting operations  
    + Full audit trail and traceability of all agreement activities 

Master Data Management (Partners, Products & Studies)

Ennov provides a central master data layer to support consistency and governance across agreements and obligations.

  • Master data domains 
    + Partners, vendors, affiliates, and contacts 

    + Products and safety profiles 
    + Marketing authorization status by country 
    + Clinical studies and development programs 

  • Governance & control  

    + Maintain a single source of truth for all PV-relevant entities 
    + Ensure consistency across: Agreements, Safety activities, Reporting obligations 
    + Support data standardization and controlled vocabularies 

Safety Obligation Management & Responsibility Tracking

A major strength of Ennov PV Agreements is the ability to manage and monitor contractual obligations and all pharmacovigilance responsibilities tied to external partners and affiliates. The solution tracks:

  • Comprehensive Safety obligation coverage 
    + Case processing and expedited reporting 

    + Case reconciliation 
    + Aggregate and periodic reporting 
    + Literature monitoring 
    + Signal detection and management 
    + Risk management (RMP, aRMM, aPVP) 
    + Labeling and safety updates 
    + Health authority queries and responses 
    + Safety communications and notifications 
    + Artwork and packaging compliance 

 

  • Responsibility matrix & execution control  

    + Define a clear responsibility matrix across partners and affiliates 
    + Assign owners, timelines, and deliverables for each obligation 
    + Link obligations directly to: Agreements, Products, Regions and partners  

  • Process, tracking & notifications  
    + Configurable workflows for execution, review, and approval of obligations 
    + Real-time tracking of status, completion, and compliance
    + Automated notifications for: Upcoming or overdue obligations, Required actions and approvals
    + Escalation management to ensure on-time delivery and compliance 

Each obligation can be assigned owners, deadlines, escalation rules, and completion evidence to ensure operational accountability across all parties. 

Global and Local Oversight, Tracking & Governance

Ennov PV Agreements provides a unified framework to manage contracts, obligations, and execution activities:

  • Centralized task and workload management across teams and partners 
  • End-to-end traceability of commitments and deliverables
  • Real-time visibility into compliance risks and operational gaps 

  • Full audit trail for inspections and regulatory reviews

Organizations can maintain centralized governance while allowing local teams to manage region-specific obligations within a unified system.

Analytics, Dashboards & KPIs

Ennov delivers data-driven insights and performance monitoring across agreements and safety obligations.

  • Operational dashboards 
    + Overview of agreement status (active, expiring, under review) 

    + Tracking of obligation execution across partners and regions 
    + Visibility into compliance status and risk areas 

  • Key performance indicators (KPIs) 
    + Timeliness of obligation completion 

    + Adherence to reporting timelines and commitments 
    + Renewal and contract lifecycle performance 
    + Partner and vendor compliance metrics 
    + Workload distribution and operational efficiency

  • Advanced analytics 

    + Identification of bottlenecks and delays in obligation execution 
    + Trend analysis across partners, products, and regions 
    + Support for continuous improvement and governance optimization  

  • Inspection readiness 

  • Generate audit-ready reports and evidence 

  • Provide full visibility into:
    + Agreements
    + Responsibilities
    + Execution performance

Business Benefits

By implementing Ennov PV Agreements, pharmaceutical companies can achieve:

Ennov transforms Pharmacovigilance Agreement Management from a fragmented, document-centric process into a fully traceable, workflow-driven operational system that supports proactive compliance management across the global safety ecosystem. 

  • Reduced compliance risk
  • Improved partner oversight
  • Faster agreement lifecycle management
  • Enhanced inspection readiness
  • Reduced manual tracking activities
  • Better visibility into global safety obligations
  • Stronger collaboration across affiliates and partners
  • Increased operational efficiency and governance

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

How can we help you?

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