For every marketing authorization holder (MAH), pharmacovigilance is not just another operational function — it often becomes a constant source of pressure. MAHs are expected to monitor safety, manage risks, and remain inspection-ready at all times, while regulatory expectations continue to grow and evolve.
The problem is that most marketing authorization holders quickly find themselves caught between responsibilites. Even when pharmacovigilance services are outsourced, accountability does not transfer. MAHs remain responsible for every adverse event, every report, and every inspection outcome — yet depend on external partners to deliver them.
This creates a critical gap.
Processes become fragmented, oversight becomes unclear, and compliance risks start to build quietly in the background — until they surface on the worst possible time — during an audit or inspection.
And that’s where the real challenge begins: how do you choose pharmacovigilance services that actually work for a marketing authorization holder — without losing control or compliance?
What marketing authorization holders must do to stay compliant — and why most fail
For marketing authorization holders, the expectation is clear: you must operate a fully functional pharmacovigilance system that continuously monitors the safety of your product(s) and ensures compliance with EU and local legislation.
But in practice, this is where the problem begins.
Most marketing authorization holders approach pharmacovigilance as a combination of outsourced tasks rather than a controlled system. They rely on different vendors for case processing, reporting, or signal detection, assuming that compliance will naturally follow. It doesn’t. What actually happens is fragmentation — data sits in different places, responsibilities become unclear, and oversight weakens over time.
At the same time, regulatory expectations do not adapt to your setup. Authorities expect you to have full control, full visibility, and a system that works continuously — not only when preparing for inspections. Even when activities are delegated, the responsibility remains entirely with the marketing authorization holder, including the performance of third-party providers.
This creates a structural gap. You are accountable for compliance, but your system is often built on dependencies you do not fully control. To close that gap, marketing authorization holders must shift their approach. Pharmacovigilance must be designed as an integrated system, where processes, responsibilities, and data flow are aligned from the beginning. It requires clear governance, continuous oversight, and the ability to scale as product complexity increases. Without this, even well-intentioned setups fail under pressure — especially during inspections, where authorities assess whether your system actually functions in reality. This is exactly where most companies struggle.
Why Billev Pharma East is the right choice for marketing authorization holders
At this point, the decision becomes very clear for marketing authorization holders: you can either continue managing fragmented pharmacovigilance activities — or you can implement a system that is designed to work under real regulatory pressure.
This is where Billev Pharma East becomes the difference.
Unlike traditional pharmacovigilance vendors, who typically operate through fragmented service models and task-based outsourcing, we don’t approach pharmacovigilance as isolated activities. We deliver a fully integrated pharmacovigilance system built specifically for marketing authorization holders — one that ensures compliance, control, and inspection readiness from day one.
What makes this critical is how regulatory expectations have evolved. Marketing authorization holders are now expected to demonstrate not just compliance, but continuous oversight, auditability, and full control over both internal and outsourced activities.
Most pharmacovigilance vendors cannot operationalise this. We do.
At Billev Pharma East, we translate complex regulatory requirements into systems that actually function in daily operations. We design and maintain your pharmacovigilance system, implement and manage your PSMF, provide QPPV oversight, and ensure that every activity — from adverse event reporting to signal detection in pharmacovigilance — is aligned, documented, and inspection-ready.
What truly positions us as the right partner is ownership. We do not operate as an external vendor — you gain a team that works as an extension of your organisation, with deep experience across EU, local, and global regulatory frameworks and direct collaboration with authorities such as EMA and national competent bodies.
The result is not just compliance. It is a carefully designed and implemented pharmacovigilance system that is structured, scalable, and defensible under inspection. Because for marketing authorization holders, the real risk is not choosing between pharmacovigilance vendors. It is choosing a model that fails when regulators start asking questions. And that is what we are here to prevent.
What pharmacovigilance services actually include for marketing authorization holders
To understand how to choose the right partner, marketing authorization holders must first understand what pharmacovigilance services actually cover in practice.
Pharmacovigilance is not a single activity — it is a continuous system designed to monitor, assess, and protect the safety of medicinal products throughout their lifecycle.
For every marketing authorization holder, this system must be fully operational from the moment a product is authorised, continue without interruption after it is placed on the market and even after the product is taken off market. EU law explicitly requires each marketing authorization holder to operate a pharmacovigilance system as part of the overall regulatory framework.
In practical terms, pharmacovigilance services typically include the collection and evaluation of adverse events, continuous safety monitoring, and reporting obligations to regulatory authorities through systems such as EudraVigilance. These activities ensure that any emerging risks are identified early and managed appropriately.
A critical part of this system is also the preparation of Periodic Safety Update Reports (PSURs), where marketing authorization holders must provide a structured, ongoing evaluation of the product’s benefit–risk balance based on accumulated safety data.
Beyond this, marketing authorization holders must also maintain structured documentation and processes that demonstrate how their pharmacovigilance system operates. This includes elements such as a pharmacovigilance system description, risk management planning, and ongoing safety evaluation of the product’s benefit–risk balance.
What makes this particularly complex is that pharmacovigilance is not static. Regulatory requirements continue to evolve, with new expectations around signal management, oversight of third-party providers, and risk-based compliance approaches.
This means that for marketing authorization holders, pharmacovigilance services are not just about execution. They are about ensuring that the entire system remains compliant, scalable, and aligned with regulatory expectations at all times.
And that is exactly why choosing the right approach — and the right partner — becomes a strategic decision, not just an operational one.
How inspection reality should shape your choice of pharmacovigilance services
For marketing authorization holders, the decision about pharmacovigilance services becomes much clearer when you understand one thing: regulators do not evaluate promises — they evaluate your system in action.
EU pharmacovigilance inspections are specifically designed to verify whether a marketing authorization holder has the people, processes, and systems in place to meet its obligations, and whether those elements actually function in practice. This is where many companies fail — not because they lack a provider, but because their setup is not built to withstand real scrutiny.
Inspectors have the authority to review your entire pharmacovigilance environment. They can examine your Pharmacovigilance System Master File (PSMF), your internal processes, your data flows, and even the third-party providers you rely on. In other words, outsourcing does not reduce visibility — it expands the scope of what must be controlled.
At the same time, regulatory expectations are very explicit: a marketing authorization holder remains responsible for ensuring that both internal teams and external partners comply with all pharmacovigilance requirements. This creates a direct connection between your vendor choice and your regulatory risk.
If your pharmacovigilance model is fragmented, if responsibilities are unclear, or if oversight is limited, those weaknesses will not remain hidden. They will surface during inspection — often as findings that require corrective actions, or in more serious cases, regulatory consequences. That is why the selection of pharmacovigilance services must be aligned with inspection reality.
For marketing authorization holders, the goal is not to “have services in place.” It is to ensure that your entire pharmacovigilance system is defensible, transparent, and fully operational under regulatory review. Because ultimately, compliance is not judged by structure alone. It is judged by how your system performs when it is tested.
Choosing the right pharmacovigilance partner is a strategic decision for marketing authorization holders
For marketing authorization holders, pharmacovigilance is not just a regulatory obligation — it is a continuous responsibility that defines whether your product remains compliant, safe, and on the market. The critical point is this: even when activities are outsourced, the marketing authorization holder remains fully accountable for how the system performs and how compliance is demonstrated.
This is exactly why the final decision is not about selecting a service provider. It is about choosing a partner who can take your regulatory responsibility and turn it into a system that actually works in practice.
At this stage, Billev Pharma East becomes the logical choice.
As a specialised partner working directly with EU authorities and regulatory frameworks, Billev Pharma East delivers fully integrated pharmacovigilance solutions tailored for marketing authorization holders, covering everything from system setup and QPPV oversight to signal detection, reporting, and inspection readiness.
What sets this apart is not just the scope of services — but the model behind them. Instead of fragmented pharmacovigilance outsourcing, Billev Pharma East provides a connected, end-to-end pharmacovigilance system, integrating regulatory, safety, and quality functions into one coherent structure.
This means that as a marketing authorization holder, you gain:
- a system that is operational from day one
- continuous oversight and control
- readiness for audits and inspections at any time
More importantly, you gain a partner who understands that your responsibility never disappears — and builds everything around protecting it.
If you are a marketing authorization holder looking for a pharmacovigilance partner that ensures real compliance, not just formal coverage, Billev Pharma East is the step forward.
Read also:
- Alternatives to Big Pharma PV Vendors: how to choose the right pharmacovigilance vendors
- Signal detection in pharmacovigilance: how to choose the right service partner
- Best firms for Post-Market Surveillance (PMS) and complaints: how to choose the right PMS partner
Sources: 1 – European Medicines Agency. (n.d.). Good pharmacovigilance practices (GVP), 2 – European Medicines Agency. (n.d.). Periodic safety update reports (PSURs), 3 – European Medicines Agency. (n.d.). Pharmacovigilance system: questions and answers, 4 – European Medicines Agency. (n.d.). Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file, 5 – European Medicines Agency. (n.d.). Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report, 6 – UK Government (MHRA). (n.d.). Guidance on pharmacovigilance procedures, 7 – Austrian Federal Office for Safety in Health Care (BASG). (n.d.). FAQ pharmacovigilance, 8 – Italian Medicines Agency (AIFA). (n.d.). Periodic safety update reports (PSUR).
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