QPPV Oversight: What Good Looks Like

The Qualified Person for Pharmacovigilance (QPPV) must demonstrate end-to-end

oversight of the safety system. Without structure, responsibilities blur, meeting

notes disappear, and regulators question who is truly in charge.

This playbook lays out a crisp oversight model. You will define the oversight

plan, track KPIs that matter, capture governance minutes, and document proactive

engagement so you can prove continuous control.

Why deliberate oversight matters

Regulatory expectation: EU regulators expect the QPPV to have authority and

detailed knowledge of the PV system. Inspections often center on oversight

evidence.

Patient protection: Clear visibility into signals, case processing, and

CAPAs ensures safety issues escalate quickly.

Affiliate alignment: Markets rely on QPPV direction for compliance. Consistent

communication builds trust.

Operational resilience: Documented oversight supports backup coverage and

scalability during growth or acquisitions.

Step 1: Document an annual oversight plan

Outline key activities: signal review board participation, PSUR/PBRER approval,

vendor oversight meetings, affiliate interactions, system audits, training

reviews.

Set frequencies (monthly, quarterly, annually) and align with regulatory

reporting calendars.

Include escalation thresholds and contact trees for urgent safety issues.
Define backup responsibilities when the QPPV is unavailable, ensuring deputies

have training and system access.

Step 2: Build an oversight dashboard

Track KPIs covering case timeliness, data quality, signal management, CAPA

closure, audit findings, SAE reconciliation, and literature compliance.

Visualize trends over time with thresholds that trigger QPPV review.
Integrate data from safety systems, quality management, and vendor reports.
Review the dashboard before every governance meeting; annotate decisions.

Step 3: Run structured governance meetings

Schedule recurring QPPV governance sessions with PV leadership, quality,

medical, and regional representatives.

Use a consistent agenda: KPI review, signal status, inspection readiness,

partner updates, outstanding CAPAs.

Capture minutes with decisions, actions, owners, and due dates. Store them in a

controlled repository linked to the oversight plan.

Follow up on actions between meetings and document closures.

Step 4: Demonstrate vendor and affiliate oversight

Maintain a log of engagements with CROs, case-processing partners, and

affiliates. Include meeting dates, topics, and outcomes.

Review vendor KPIs (quality, timeliness, training) and document interventions.
Provide affiliates with written guidance and track confirmations of receipt.
Conduct periodic audits or assessments; record findings and remediation plans.

Step 5: Capture proactive risk management

Document how emerging risks are identified and escalated to the QPPV.
Maintain records of QPPV input into risk management plans, labeling decisions,

and regulatory responses.

Highlight examples where the QPPV initiated improvements or preventive actions.

Metrics that prove effective oversight

Percentage of oversight actions completed on time.
Time from safety issue identification to QPPV awareness.
Inspection feedback and absence of QPPV-related findings.
Vendor and affiliate performance trends post-intervention.
Training completion for QPPV, deputies, and key staff.

45-day roadmap

Days 1-10: Map current QPPV interactions, identify documentation gaps, and

collect historic evidence.

Days 11-20: Draft the annual oversight plan and validate with quality and

regulatory leads. Publish the plan in a controlled environment.

Days 21-30: Launch the KPI dashboard, align data sources, and schedule

governance meetings with defined agendas.

Days 31-45: Capture minutes, execute follow-up actions, and compile a

portfolio of oversight evidence ready for inspection.

Frequently asked questions

What evidence do inspectors expect? Oversight plan, meeting minutes, KPI

trends, intervention records, and proof of QPPV involvement in major decisions.

How many KPIs are enough? Focus on high-impact metrics. Ten well-defined

KPIs reviewed regularly beat thirty ignored metrics.

Do deputies need full access? Yes. Train them and document competence so

regulators see continuity.

How often should the plan be updated? At least annually and whenever

significant organizational or portfolio changes occur.

Sustain the win

Review oversight plans quarterly, refresh KPIs when the portfolio changes, and

rotate minute-taking duties to keep documentation sharp. Share success stories

when early QPPV interventions averted risk. Proactive oversight becomes a hallmark

of a mature safety organization.