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In 2026, pharmacovigilance systems are more digital, more decentralized, and more interconnected than ever. Yet one risk continues to be underestimated across organizations — especially during inspections.
It’s not always your core safety vendor.
It’s the vendor that was never labeled “PV” in the first place.
We’re talking about organizations that interact directly with patients or healthcare professionals and, as a result, may receive safety information — even though pharmacovigilance is not their primary function.
These commonly include:
Patient Support Programs (PSPs)
Patient Assistance Programs (PAPs)
Hub service providers
Specialty pharmacies
Certain Market Research Programs (MRPs)
These are legitimate and often commercially critical partners. But from a regulatory perspective, they are also potential primary sources of Individual Case Safety Reports (ICSRs).
And regulators are paying attention.
Inspection trends over the past few years continue to show findings in:
Delayed transmission of safety cases from PSPs and hubs
Inadequate PV training for frontline vendor staff
Weak reconciliation processes
Poor visibility into subcontracting chains
Vague or misaligned contractual language
Insufficient MAH oversight controls
At the same time, Implementing Regulation (EU) 2025/1466 has reinforced expectations around subcontracted pharmacovigilance activities. The regulation emphasizes:
Clearly defined responsibilities
Robust safety data exchange arrangements
MAH control over further subcontracting
Explicit audit and inspection rights
Demonstrable oversight of third parties handling safety information
The regulatory position is straightforward:
If safety data can originate from the vendor, PV obligations apply — regardless of what the commercial contract calls them.
Managing these vendors effectively requires a structured, risk-based lifecycle approach. Oversight cannot be superficial or template-driven. It must reflect the actual risk profile of the vendor’s activities.
Below is a practical framework that organizations in 2026 are adopting.
Before go-live, the Marketing Authorization Holder (MAH) must assess vendor capability proportionate to risk.
This includes:
Evaluating the likelihood of safety data capture
Reviewing call scripts and intake workflows
Assessing escalation pathways and reporting timelines
Identifying subcontracting layers
Understanding data system interfaces
For lower-risk vendors, a structured questionnaire may be sufficient. For higher-risk models — especially those with high patient interaction — a targeted audit may be warranted.
A key point under EMA GVP Module IV remains critical:
A questionnaire assessment is not an audit.
Terminology must reflect the activity performed. Mislabeling creates inspection vulnerability.
Contracts must align with real operational activities, not generic language.
Fit-for-purpose agreements should include:
Explicit ICSR reporting timelines (e.g., 1 business day notification)
Clear definitions of reportable safety information
Mandatory PV training requirements
Audit and inspection rights
MAH approval rights for subcontractors
Defined escalation pathways
Baseline QMS expectations proportionate to GxP activities performed
One of the most common inspection findings remains vague language such as:
“Vendor will forward safety information in a timely manner.”
Regulators expect measurable timelines — not subjective commitments.
Oversight does not end at contract signature.
Effective ongoing governance includes:
Defined KPIs and KQIs
Routine reconciliation between vendor records and the MAH safety database
Training compliance monitoring
Periodic governance meetings
Formal escalation and deviation processes
Documented risk re-assessments
The MAH must retain the ability to trigger deviations and CAPAs if commitments are not met.
Oversight must be demonstrable, documented, and inspection-ready.
These vendors should not be treated as afterthoughts within the audit program.
Instead, they require:
A defined vendor category
Risk-based audit frequency
Scope tailored to safety touchpoints
Review of subcontractor controls
Verification of training and reporting compliance
Calendar-driven audit cycles without documented risk rationale are increasingly questioned by inspectors. Conversely, failure to audit high-risk PSP or hub vendors is frequently cited.
In 2026, safety data flows through:
Call centers
Specialty pharmacies
Digital engagement platforms
Real-world evidence programs
AI-enabled patient interfaces
Commercial partner ecosystems
Pharmacovigilance is no longer confined to the safety department. It is embedded within the commercial and patient engagement landscape.
Organizations that fail to recognize this create silent risk accumulation — often discovered only during inspection.
The most persistent misconception remains:
“They are not a PV vendor.”
Regulators do not audit labels.
They audit data flow, accountability, and control.
Fit-for-purpose oversight of PV-related vendors is not optional in 2026. It is a core component of inspection readiness and risk management maturity.
The question is no longer whether these vendors require oversight.
The question is whether your oversight model is strong enough to withstand inspection.