I recently attended the DIA QPPV forum in Amsterdam, an event that once again highlighted the strength, expertise and collaboration within the pharmacovigilance community. It was an invaluable few days of networking, knowledge sharing, and connecting with people who are equally committed to advancing patient safety and regulatory excellence. In summary what stood out to me from the different sessions was: increasingly complex outsourcing chains, expanding local requirements, and growing expectations of QPPVs and QPPV offices to maintain robust oversight despite rapidly evolving systems.

At Sagittal Pharma, where we have a QPPV office, oversee our Local Safety Officer (LSO) network and work alongside and support our network of QPPVs, the sessions resonated strongly with the challenges – and opportunities – we face in ensuring global consistency, local accuracy, and end-to-end accountability.

Below were my key takeaways:

QPPV Responsibilities Are Broadening – complex outsourcing chains

There is a strong regulatory imperative for full oversight, even when activities are deeply outsourced or subcontracted.

· Outsourcing does not reduce accountability. The MAH and QPPV remain fully responsible, regardless of how many service providers or subcontractors sit in the chain.

· Mapping the outsourcing chain is essential. Identifying who does what, where responsibilities begin and end, and what oversight mechanisms exist must be formalised – not assumed.

What I found particularly useful was the emphasis on risk-based oversight – shifting attention toward high-risk activities rather than attempting to scrutinise everything equally. Digital dashboards, automated alerts, and stronger communication pathways were highlighted as practical tools now being used to streamline oversight and maintain real-time awareness of PV performance.

QPPV oversight of LSOs – Balancing global standardisation with local realities

· There needs to be a structured, repeatable oversight cycle, and oversight only works if it is systematic, predictable, and visible across functions.

· Dashboards are becoming the backbone of PV visibility to pull together data from across PV systems and present KPIs without manual manipulation. Thus there is less manual monitoring and more integrated intelligence.

· Local oversight frameworks are being strengthened globally

· LSO oversight varies widely by country.

LSO networks thrive where there is community, clarity and connection, not just compliance.

Interactions with Bordering Functions

Oversight requires visibility – not just authority. The QPPV needs to ensure that cross-functional roles truly understand their PV responsibilities.

The QPPV’s interaction with and ability to see what is happening across Safety, Clinical, Regulatory, Quality, Commercial, Medical Information, and Patient Support Programs is foundational. Oversight mechanisms include:

· PSMF access

· monthly PV reporting

· review of SMT minutes

· involvement in governance boards

· routine meetings with key stakeholders

Stakeholder management is a discipline, not an afterthought. Some ideas of how to drive this:

· newsletters and dedicated SharePoint spaces

· internal agreements between the QPPV and senior managers

The Growing Pressures on QPPVs and QPPV Offices

Across all sessions, some shared challenges emerged:

· Organisational change creates continuous PV disruption.

· Local expectations are increasing, driven by more countries adopting GVP-like frameworks.

· Subcontractor oversight is still a regulatory hotspot, with findings often tied to unclear governance, incomplete risk assessments, and inadequate documentation.

The QPPV forum reinforced several points:

1. LSO networks need structured, documented oversight – not informal management.

2. Governance must extend through every layer – local, global, outsourced, subcontracted.

3. Digitalisation is no longer optional – Dashboards, automated alerts, and centralised data flows are becoming standard practice. They are also critical to giving QPPVs true visibility.

4. Collaboration is the differentiator – Strong cross-functional partnerships, particularly with commercial, medical, and regulatory teams, are becoming increasingly important as PV activities decentralise.

5. The PSMF remains one of the most powerful (and scrutinised) oversight tools.

For QPPV’s, and those of us supporting QPPVs and managing LSO networks, we have an opportunity to mature our frameworks, clarify expectations, streamline reporting, and lean into digital tools that strengthen our ability to protect patient safety.