Scientific Expertise. Regulatory Discipline. Global PV Operations.
VIGIVANCE delivers end-to-end pharmacovigilance and drug safety services, combining scientific rigour, regulatory discipline and continuous oversight across global markets.
End-to-end pharmacovigilance and drug safety support designed to maintain compliant, effective and inspection-ready safety systems across global markets, built on scientific rigour and continuous regulatory alignment.
11 PV Capability Areas
Eleven core areas, delivered under one accountable team, from first case intake through to signal closure and inspection readiness.
Every case enters a structured, validated workflow from first receipt, so downstream assessment, coding and reporting always build on accurate, audit-ready data.
We build and maintain the PSMF and the wider PV system behind it, keeping documentation current, defensible and ready for review at any time.
Named QPPV and deputy support gives your programme a single point of safety accountability, with oversight extended consistently across every market.
Systematic screening of global and local literature surfaces safety-relevant information early, so nothing material to your product's profile is missed.
Periodic and aggregate safety reports are prepared with rigorous data reconciliation and medical review, giving health authorities a clear, evidence-based view of your product's benefit-risk profile.
PSUR | PBRER | Aggregate Safety Assessment, supporting global products across diverse regulatory markets.
Signals are detected, validated and prioritised against multiple data sources, then carried through medical review to a documented, actionable outcome.
Data-led analysis. Expert medical interpretation. Actionable safety assessment.
Core and local RMPs are developed and kept current, with risk minimisation measures tracked through to measurable effectiveness.
Ongoing GAP and compliance assessment, paired with structured CAPA tracking, keeps your PV system inspection-ready every day, not only before an audit.
SDEAs and PV agreements are drafted, reviewed and maintained with clear responsibility mapping, so obligations across every partner stay traceable.
Digital case workflows, dashboards and reconciliation tools bring structure and traceability to safety data management, end to end.
Dedicated EU QPPV and GVP-aligned support covers the full scope of EudraVigilance, aggregate reporting and signal management obligations.
We prepare PSUR and PBRER submissions with rigorous data reconciliation and medical review at every stage, so the finished report withstands scrutiny in any market.
Cumulative safety data is assessed against the product's evolving benefit-risk profile, with signal information integrated directly into the narrative rather than treated as a separate exercise.
Our signal management process combines systematic detection with expert medical interpretation, reviewing multiple safety data sources rather than relying on a single feed.
Every signal is tracked through validation, evaluation and regulatory assessment to a documented, defensible closure.
End-to-End Pharmacovigilance, From Case Intake to Signal Closure
Core PV capability areas delivered under one accountable team.
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