SDEA and Vendor Oversight Case Study

Fixing the SDEA Breakdown

How PVCON helped a pharmaceutical organisation standardize partner agreements, clarify responsibilities, and restore control over safety-data reconciliation.

The Agreements Were in Place. The Handoffs Were Not.

The organisation was managing pharmacovigilance activities across multiple external partners, with Safety Data Exchange Agreements defining how safety information should move between parties.

But the agreements were not working consistently in practice.

Requirements differed across SDEAs, partner responsibilities were not always clear, and reconciliation activities were not being completed with the consistency expected.

Over time, these gaps contributed to a backlog of 160 reconciliation records and increased the risk of delays in safety-data exchange and reporting.

The issue was therefore not simply an outdated agreement template.

The organisation needed stronger alignment between what each SDEA required and how partners actually performed their responsibilities within the wider pharmacovigilance quality system.

Turning SDEAs Into Working Operational Controls

PVCON reviewed and standardized 28 SDEAs, creating greater consistency across key safety-data exchange requirements.

Responsibilities between parties were clarified so that ownership of important PV activities was easier to understand and follow.

The engagement also strengthened the operational controls around the agreements.

Reconciliation controls were introduced to support more consistent follow-up and stronger PV governance and oversight. Escalation rules defined how delayed or unresolved items should be managed, while vendor metrics created greater visibility over partner performance.

This shifted the SDEA framework from a collection of individual agreements toward a more consistent oversight model connecting contractual responsibilities with day-to-day execution.

Where the Control Model Changed

Control Area	Existing Gap	PVCON Intervention	Measured Improvement
SDEAs	Agreements were inconsistent	28 SDEAs standardized	Greater consistency across partner requirements
Responsibilities	Partner ownership lacked clarity	Roles and responsibilities clarified	Clearer accountability across parties
Reconciliation	160 records remained backlogged	Reconciliation controls introduced	Backlog cleared within 6 weeks
Escalation	Delayed items lacked consistent escalation	Escalation rules established	Stronger follow-up of unresolved items
Vendor Oversight	Limited performance visibility	Vendor metrics introduced	On-time reconciliation improved from 81% to 97%

Clearing the Backlog and Restoring the Rhythm

The operational impact was visible within weeks.

The 160-record reconciliation backlog was cleared within 6 weeks, removing a significant accumulation of unresolved activity.

At the same time, on-time reconciliation improved from 81% to 97%.

Standardizing all 28 SDEAs also gave the organisation a more consistent foundation for managing responsibilities, escalation and partner performance across its vendor network.

Stronger Agreements, Stronger Vendor Oversight

An SDEA can define responsibilities, but effective oversight depends on whether those responsibilities are understood, monitored and followed in practice.

For this organisation, strengthening the agreements and the controls around them helped create a clearer connection between documented responsibilities, pharmacovigilance compliance, and operational performance.

Managing complex PV partner relationships? Explore PVCON's PV consulting services or contact PVCON to strengthen SDEA governance, reconciliation and vendor oversight.