Beyond Outsourcing: Why Oversight of PV Vendors Is Critical for Compliance and Success

Outsourcing pharmacovigilance (PV) functions has become an increasingly common strategy for pharmaceutical and biotech companies. As organisations expand pipelines or reduce internal resource costs, partnering with experienced PV vendors or Contract Research Organisations (CROs) is often a strategic decision.

However, while pharmacovigilance tasks can be outsourced, legal responsibility cannot. Sponsors and Marketing Authorisation Holders (MAHs) must maintain full oversight to meet regulatory expectations.

In this blog, we explore why effective sponsor oversight is essential, common pitfalls to avoid, and actionable strategies to build a robust oversight framework.

1. The Myth: “We Outsourced It, So It’s Their Responsibility”

A common misconception is that outsourcing pharmacovigilance functions also transfers regulatory responsibility. In reality, under EU GVP Modules I and IV, and guidance from the FDA and MHRA, the MAH or sponsor retains full responsibility for ensuring that outsourced PV activities meet regulatory requirements.

This means:

• You are accountable for the quality and compliance of your vendor’s work.

• You must demonstrate continuous oversight during inspections and audits.

2. Common Oversight Pitfalls

Sponsors and MAHs often fall short in several key areas, including:

❌ Unclear roles and responsibilities in PV Agreements (PVAs)

❌ Irregular communication with vendors

❌ Limited oversight of performance metrics and compliance KPIs

❌ Lack of documented audits or vendor inspection readiness

❌ Unclear data ownership or submission processes

Such gaps can lead to critical findings during regulatory inspections—and worse, compromise patient safety.

3. Regulatory Expectations

EMA GVP Module IV states that outsourced activities must be subject to the same pharmacovigilance quality system as internal operations. Similarly:

• The MHRA routinely cites poor CRO oversight in its inspection findings.

• The FDA expects clear governance and documentation to support compliance with pharmacovigilance responsibilities.

These agencies expect sponsors to review data regularly, monitor vendor performance, and take prompt action when issues arise.

4. Best Practices for Effective PV Vendor Oversight

To meet regulatory expectations and maintain operational excellence, sponsors should:

✅ Draft comprehensive PV agreements (PVAs) that define responsibilities, timelines, data flow, and escalation procedures.

✅ Implement clear KPIs and performance metrics, such as ICSR processing times and compliance with submission timelines.

✅ Hold regular governance meetings with vendors to discuss performance, deviations, and process improvement.

✅ Conduct vendor audits, either annually or based on risk assessment.

✅ Maintain internal PV expertise to ensure knowledgeable oversight and alignment with regulatory requirements.

5. PV Vendor Oversight Framework: A Quick Checklist

📌 PVA signed and regularly reviewed

📌 Roles and responsibilities clearly documented

📌 SOPs aligned across sponsor and vendor

📌 KPIs monitored monthly or quarterly

📌 Risk-based vendor audit plan in place

📌 Vendor training records and deviations tracked

Final Thoughts

Outsourcing pharmacovigilance does not relieve sponsors of their regulatory obligations. On the contrary, it increases the need for structured, well-documented oversight. With the right framework in place, sponsors can safeguard compliance, strengthen vendor relationships, and most importantly—protect patient safety.

If you’re considering outsourcing PV activities or looking to enhance your current vendor oversight model, Drug Safety Services can help. Whether you need interim oversight, PVA review, or inspection preparation, we offer flexible support tailored to your organisation’s needs.

If you have questions about your responsibilities or need support with pharmacovigilance vendor oversight activities, feel free to contact me at amanda@drugsafetyservices.co.uk or connect via LinkedIn.