Simplify PVA Management and Improve Inspection Readiness

Mar 23, 2026 | Christina Kim and Celine Ghafari

This edition of Veeva’s Safety newsletter covers how simplifying oversight and collaboration of pharmacovigilance agreements (PVAs) and safety data exchange agreements (SDEAs) across the partner ecosystem improves operational efficiency and inspection readiness.

PVAs and SDEAs: Collaboration and compliance challenges

Managing pharmacovigilance agreements (PVAs) and safety data exchange agreements (SDEAs) across multiple partners, products, and markets is operationally complex. At the same time, there is also greater scrutiny from health authorities on how companies manage and demonstrate oversight of partner PV responsibilities during inspections.

Yet many organizations still rely on spreadsheets, email, and multiple tools to track agreement obligations and partner activities. These manual processes make it difficult to maintain visibility across agreements, partners, and products — impacting operational efficiency and increasing compliance risk.

Common efficiency challenges include:

• Limited oversight of PVA-defined obligations. Tracking PVA responsibilities in spreadsheets provides little visibility into task status or completion, such as safety data exchange timelines, case processing and submissions, aggregate reporting, and updates to risk management plans. It is difficult to monitor partner obligations, confirm approved agreements and applicable responsibilities at a given point in time, and maintain consistent oversight across agreements.
• Fragmented processes and inefficient partner collaboration. Managing agreements, tracking obligations, and coordinating activities through email and spreadsheets makes it difficult to collaborate and ensure timely completion of pharmacovigilance obligations. Challenges become more acute as the number of agreements or reporting requirements grow.
• High overhead to demonstrate compliance during audits and inspections. Without structured tracking of agreement obligations and partner activities, organizations struggle to demonstrate clear oversight during audits and regulatory inspections. Reconstructing evidence of responsibilities, communications, and completed tasks often requires time-consuming manual reconciliation, and managing activities in non-validated systems further increases compliance risk.

Operationalize PVA management for greater oversight and efficiency

Managing PVAs and SDEAs in a validated solution designed for pharmacovigilance enables structured oversight of partner obligations and greater transparency and collaboration between sponsors and partners.

For organizations expanding partnerships, or navigating mergers and acquisitions, PVA management in a purpose-built system is more efficient, scalable, and consistent across global teams. A unified approach reduces manual effort and compliance risks by establishing:

• Structured and documented oversight of partner obligations. Gain real-time visibility into PVA-defined responsibilities — including safety data exchange, case handling, aggregate reporting, risk management plan updates, and safety labeling changes — with clear tracking of tasks, timelines, and completion status.
• Centralized lifecycle and multi-agreement management. Author, version, approve, and maintain PVAs and SDEAs in a centralized environment while linking agreements to products, partners, and associated obligations. Manage activities across multiple agreements to efficiently address changes that impact multiple partners.
• Improved partner collaboration and coordination. Structured workflows and shared visibility help internal teams and partners coordinate activities, track responsibilities, and ensure timely completion of pharmacovigilance obligations.
• Event-based activities and automated processing. Trigger activities across agreements when key safety events occur — such as confirmed safety signal investigations and updates to risk management plans or pharmacovigilance system master files (PSMFs) — and capture inbound partner communications to generate and assign obligations.

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