Pharmacovigilance (PV) covers the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It’s a fundamental part of patient safety, ensuring that new treatments remain as safe in the real world as they were in clinical trials.
But as regulatory requirements multiply and drug pipelines globalize, PV has become increasingly complex. Companies operating across borders must manage not only safety data, but also the project governance structures that hold it all together.
Project governance refers to the frameworks that define who is responsible for what, the flow of information, and how decisions are made. In PV, strong governance ensures that issues aren’t missed and compliance deadlines are met—effectively ensuring that collaboration runs smoothly and nothing slips through the cracks.
Making global coordination manageable
One of the biggest challenges in pharmacovigilance is trying to align operations across different countries. Regulatory requirements vary widely depending on the country—some demand a full local PV presence from a company, while others focus on harmonized reporting through regional hubs. Without appropriate governance, discrepancies can lead to costly inconsistencies and compliance gaps.
“Without appropriate governance, discrepancies can lead to costly inconsistencies and compliance gaps.”
To prevent this, companies need governance that includes clear reporting lines, well-defined roles and responsibilities, and oversight mechanisms that work across continents. In practice, this could mean setting up a centralized PV office with designated local points of contact, standardized templates for adverse event reporting, and escalation pathways for high-risk cases. Regular governance board meetings or steering committees can also help keep everyone aligned, whether the PV activities are handled in-house or outsourced to a partner.
Outsourcing without losing control
Many biopharma companies—especially small to mid-sized firms—choose to outsource pharmacovigilance to specialized providers like QbD Group. This allows their internal teams to focus on core R&D and clinical activities, while still ensuring that safety monitoring is handled by experts.
However, outsourcing only works when governance structures are strong. Transparency is key: sponsors need access to real-time data, performance metrics, and compliance indicators. Dashboards, KPIs, and frequent review meetings help keep sponsors informed and in control, without requiring them to manage day-to-day operations. Good governance also defines who has the authority to make important decisions up front, preventing miscommunications or delays when safety decisions need to be made quickly.
“Good governance also defines who has the authority to make important decisions up front.”
As an example, a clinical-stage biotech launching its first global trial might work with a PV partner that provides local Qualified Persons (QPPVs) in each region, while maintaining a single global safety lead. That structure allows for both local compliance and centralized oversight—a model that has become increasingly common.
Governance as a quality and risk management tool
Governance is not just about process—it’s about outcomes. A well-structured governance framework supports quality assurance, audit readiness, and continuous improvement. It ensures that Corrective And Preventive Actions (CAPAs) are tracked and followed up, that regulatory changes are implemented proactively, and that systems are ready for inspection at any time.
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This kind of operational discipline is particularly critical when it comes to technology. Modern pharmacovigilance systems rely on automation more than ever, including AI and validated safety databases. To implement these tools, companies need to be able to maintain data integrity and protect patient information at all costs. Regulators are increasingly scrutinizing how companies validate and manage their digital tools, so companies need to take care to determine their governance carefully and upfront.
From compliance to competitive advantage
Although strong governance is often seen as a regulatory necessity, it can also be a strategic asset—especially in a complex industry like biopharma. Companies can speed up notoriously slow drug development timelines, using clear oversight, smooth cross-department collaboration, and timely safety data to accelerate decision-making and enable greater agility. When done right, governance helps companies move faster without cutting corners.
For global companies managing assets across multiple markets—or startups preparing for a product launch—embedding governance early can reduce costly delays and build credibility with regulators and partners alike. Ultimately, effective governance transforms pharmacovigilance from a reactive function into a proactive driver of trust, transparency, and long-term success.
