The role of the QPPV is pivotal not only to regulatory compliance but also to shaping organisational resilience and patient safety culture. Over her career, Debora De Franciscis has navigated three very different scenarios, each demanding a unique strategic and managerial approach.
In this conversation, she shares her strategic approach, practical insights, and real-life examples across three scenarios:
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Joining a company with an existing PV system, focusing on continuous improvement.
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Setting up a PV system from scratch, as the company’s first QPPV after obtaining the first Marketing Authorisation.
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Integrating an acquired company’s PV system into an existing global framework.
Scenario 1 – Taking over an existing PV system
Q: Debora, what were your priorities when you joined a company where the PV system was already in place?
Debora:
The first step was a diagnostic phase, beginning with a gap analysis against GVP modules and local regulatory requirements. This included reviewing SOPs, agreements with vendors and partners, compliance metrics (such as case processing timelines, PSMF quality, and signal detection cycles), and interviewing both the PV team and cross-functional stakeholders. In addition, an in-depth review of the MAH’s product portfolio was essential to gain a comprehensive overview of the authorised medicinal products and ensure that the pharmacovigilance system was adequate and effective for each individual product.
The analysis revealed that operators were spending disproportionate time filtering irrelevant literature hits. To address this, I drove digital innovation by implementing an automated literature monitoring platform.
This delivered two key advantages:
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Efficiency: The system reduced operator efforts by 50%, particularly critical in high-volume therapeutic areas.
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Quality assurance: built-in algorithms filtered duplicates and non-relevant hits, while a second-level manual review safeguarded quality and compliance.
Another tangible improvement was the introduction of KPI dashboards visible to senior leadership. Instead of PV being invisible, management could see at a glance the timelines, case volumes, and compliance rates. This transparency not only secured additional resources but positioned pharmacovigilance as a strategic contributor to business success.
Q: Can you share a specific process improvement that had a clear impact?
Debora:
Yes, one was the introduction of cross-functional signal detection meetings. Instead of PV working in isolation, we set up monthly reviews with Medical Affairs, Regulatory, and Quality. This created early awareness of potential issues and ensured faster decision-making. Over time, it also fostered a culture of shared responsibility for patient safety.
Another big challenge was an overgrown SOP system. SOPs/WIs covered pharmacovigilance and quality-related activities, many overlapping, some outdated, and several contradicting each other.
We launched a SOP harmonisation project with four goals:
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Reduce volume: consolidate multiple overlapping SOPs into streamlined master procedures.
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Improve clarity: use consistent terminology, aligned with GVP modules.
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Enhance usability: make them practical for staff, supported by clear flowcharts and RACI matrices.
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Always ensure compliance with the applicable regulations in force.
Training compliance improved because employees no longer felt overwhelmed. During inspection, auditors specifically noted that the streamlined SOP structure facilitated traceability and consistency, making the system easier to evaluate.
Scenario 2 – Building a PV system from scratch
Q: How different is the approach when you are the very first QPPV of a company, right after its first Marketing Authorisation?
Debora:
It’s fundamentally different. Here, you’re not optimizing, you’re building the architecture. You start from zero: SOPs, PSMF, safety database, vendor agreements, global literature screening, training programs, all need to be designed and implemented.
The challenge is that small or mid-sized companies often underestimate the complexity. They see PV as a regulatory requirement, but not as an organisational system. So, my role was not just operational but also educational and change-management oriented.
Q: What are the concrete steps to implement when you are the company’s first QPPV right after the first MA?
Debora:
The way I it is through a clear roadmap.
In the first month, I focus on governance. That means setting up a PV Steering Committee, defining escalation pathways, and appointing a Deputy QPPV or local contacts where required. I also prepare the skeleton of the Pharmacovigilance System Master File. At this stage, managerial skills are critical, you must align stakeholders quickly and secure budget, often explaining to executives why PV infrastructure is not optional.
From month two to three, I move into system design. This is when we translate GVP requirements into an operating model: process maps for case intake, ICSR processing, literature monitoring, signal management, and aggregate reporting. It’s also the phase where we choose technology.
By the second quarter, the focus is on building and validating. SOPs must be drafted, consolidated, and approved. Vendors must be contracted, with clear Safety Data Exchange Agreements. Systems need validation in line with Annex 11.
At the same time, training begins, not just for PV staff, but across the company. Sales reps, medical liaisons, and even senior managers all need tailored modules to understand their role in pharmacovigilance.
Between months six and nine, the system goes live. This is a fragile period, so monitoring is key: case processing dashboards, compliance reports, reconciliation checks. I usually plan a mock inspection to stress-test the system. In one case, we discovered affiliates were misinterpreting the definition of ‘Day 0’. Catching that before the real inspection was invaluable.
Finally, by the end of the first year, it’s time to optimise. At this stage, I look at automation: for example, web-based adverse event intake forms or automated literature screening tools. I also conduct vendor performance reviews and scale the system for new markets. Importantly, I run an Annual Management Review of the PV system, presenting KPIs to executives in a way that links safety performance with business risk.
At every phase, the managerial challenge is the same: balance regulatory rigor with organisational pragmatism.
You need to be fluent in both worlds, the language of inspectors and the language of executives. That dual fluency is what makes a PV system sustainable.
Scenario 3 – Integrating an acquired company’s PV system
Q: Debora, what happens when a company acquires another with its own pharmacovigilance system? How do you approach integration?
Debora:
Integration after an acquisition is probably the most complex scenario a QPPV can face, because you are merging two living organisms. Both systems are usually compliant on their own, but they differ in processes, databases, vendors, and even safety culture.
The first step is always to establish governance for the transition. You cannot improvise. We set up a joint PV Transition Committee with representatives from both companies, define a transition period, typically 6 to 12 months, and map responsibilities clearly. During this period, dual systems often run in parallel, but roles and escalation pathways must be unambiguous. Managerially, this is about clarity and communication: people need to know who does what, and when.
The second phase is diagnostic. We performed a detailed gap analysis between the two PV systems: databases, SOPs, literature processes, vendor agreements, signal detection practices. In one case, the acquired reality was still working with a small, local safety management and outsourced all literature screening to a niche provider, while the acquiring company had a validated database and automated global literature searches. My task was to evaluate which elements to preserve, which to migrate, and how to ensure nothing fell through the cracks.
Next comes data migration. This is a sensitive step, because historical safety data must remain traceable. In one integration, we decided to migrate all active cases into the parent company’s database while keeping the legacy system read-only for auditability. This required not only IT and validation expertise, but also strong project management, planning cutover weekends, conducting reconciliation checks, and ensuring continuity of expedited reporting. It is important also to ensure that the migration is carried out in full compliance with GDPR and other applicable data privacy regulations, particularly when personal data is included in case reports.
Another key area is vendor management. Often, both companies have overlapping contracts with service providers/third parties. Without consolidation, you risk duplication and inefficiency. In one project, I led the renegotiation process: we moved from two service providers to a single global provider, introduced harmonised KPIs (timeliness, quality, reconciliation accuracy), and scheduled quarterly reviews. This reduced costs but also raised accountability.
Then there is cultural alignment. This part is less visible but equally critical.
The acquired company’s staff were used to a reactive compliance mindset, while the parent company had a proactive culture of dashboards, signal review meetings, and inspection rehearsals. To bridge the gap, we created a joint training academy. Teams attended the same workshops, shared case studies, and practiced inspection Q&As together. Over time, this built trust and a shared vision of patient safety.
Closing note
We would like to sincerely thank Debora De Franciscis for sharing her insights and experiences across such diverse pharmacovigilance scenarios. Her perspective highlights not only the technical depth required of a QPPV, but also the leadership, communication, and change-management skills that are essential to build, transform, and integrate PV systems.
Her experience underscores a vital truth: pharmacovigilance is not a back-office function, but a strategic enabler of trust, compliance, and long-term business sustainability.
