Beyond Compliance: Transforming Pharmacovigilance Agreements Management into Strategic Safety Governance

Supporting stronger alignment, smarter safety operations, and resilient global collaborations

Introduction

What if the biggest risk in pharmacovigilance is not a missed adverse event, but uncertainty about who is responsible for managing it? As alliances become more complex, clear accountability is essential to patient safety and compliance.

At Fortrea, we view Pharmacovigilance Agreements (PVAs) as strategic governance tools that define responsibilities, enable compliant safety information exchange, and support transparent, inspection-ready collaboration.

PVAs as the Foundation of Effective Safety engagement

Global engagement requires multiple organizations to collect, assess, report, and communicate safety information. Without clear ownership, even strong systems can face delays, gaps, or inconsistent escalation.

A PVA translates regulatory expectations into practical operating rules, covering responsibilities, timelines, communication pathways, governance forums, audit rights, inspection support, and quality oversight. Treating PVAs as living governance tools helps reduce compliance risk, improve efficiency, strengthen collaboration, and maintain continuity across the product lifecycle.

Beyond Compliance: What Sponsors Expect from a PVA collaboration

Sponsors need more than a signed agreement in a repository. They need a collaborator who can translate complex requirements into practical, compliant agreements aligned with real-world safety operations.

Fortrea supports the full PVA lifecycle for over 150 PVAs/Safety Data Exchange Agreements (SDEAs)/Inter Company Agreements (ICAs), including drafting, negotiation, implementation, amendment management, periodic review, quality oversight, and termination planning.

At Fortrea we support sponsors in moving from traditional service support to strategic, end-to-end PVA management across a complex global collaborator network. Our sponsors typically span from global biopharmaceutical companies to small biotechs, and operate across more than 100 countries with a complex network of distributors, licensing collaborator, and service providers.

Fortrea has established standardized governance, clear accountability, centralized tracking, KPI-driven oversight, and proactive monitoring of contractual and compliance obligations.

This improves portfolio visibility, strengthens sponsor oversight, and creates a scalable model to support future growth.

Why Fortrea is different

Fortrea integrates PVA management within the broader pharmacovigilance ecosystem, aligning agreements with operational execution, regulatory compliance, and quality oversight.

Key differentiators include lifecycle knowledge, governance frameworks, quality-focused review, timeline adherence, inspection readiness, scalable support, and proactive regulatory monitoring.

Challenges We Help Sponsors Overcome:

• Complex global and local regulatory requirements and evolving compliance expectations
• Delays in agreement negotiation, approvals, and periodic updates
• Misalignment between contractual obligations and operational execution
• Limited visibility into agreement obligations, timelines, and compliance status
• Resource constraints associated with managing large or complex PVA portfolios
• Inspection findings or audit observations related to agreement governance and oversight

By combining regulatory intelligence, operational knowledge, and quality-driven oversight, Fortrea helps sponsors turn PVAs into strategic assets that strengthen collaboration, reduce risk, and support patient safety. Fortrea implemented a centralized PVA governance and compliance oversight model designed to transform agreement management into a strategic compliance function and implemented the below measures:

• Comprehensive review and remediation of existing PVAs.
• Creation of fit-for-purpose agreement templates based on alliance type.
• Establishment of clearly defined alliance responsibilities and escalation pathways.
• Implementation of a centralized PVA tracker to monitor agreement status, renewal timelines, obligations, and ownership.
• Structured change-management processes to manage updates in regulations, stakeholders, and business arrangements.
• Integration of compliance oversight, KPI monitoring, deviation management, and governance reporting.

Fortrea's value extends beyond agreement authoring and maintenance. By integrating PVA management with regulatory intelligence, compliance monitoring, deviation/CAPA oversight, and governance reporting, Fortrea enables sponsors in establishing a sustainable and inspection-ready PVA framework. Fortrea's model leverages dedicated PVA specialists, quality and compliance oversight, regulatory capabilities covering more than 180 countries, and experience managing over 200 PVAs annually with greater than 99% compliance performance.

Practical Steps to Strengthen a PVA Program

Sponsors can strengthen their PVA portfolio by focusing on three practical actions:

• Conduct regular PVA health checks- Confirm that agreements remain aligned with current regulations, products, reporting timelines, responsibilities, and escalation pathways.
• Focus on implementation, not just execution-Embed obligations into procedures, workflows, training, governance meetings, quality oversight, and commitment tracking.
• Collaborate with PVA specialists-Leverage a dedicated team that can support drafting, negotiation, amendments, reviews, compliance oversight, inspection readiness, and transition activities.

The real question is not whether PVAs are in place, but whether they actively support safety governance, accountability, and collaboration. With Fortrea, PVAs become a foundation for a future-ready pharmacovigilance program.