Safety & Pharmacovigilance
Safety Oversight That Protects Patients — and Your Program.
Proactive pharmacovigilance, medical review, and regulatory-ready safety systems designed to support complex trials across every phase of development.
Safety & Pharmacovigilance
Safety Oversight That Protects Patients —
and Your Program.
Proactive pharmacovigilance, medical review, and regulatory-ready safety systems designed to support complex trials across every phase of development.
Medical Monitoring & Signal Intelligence
- From Individual Cases to Meaningful Safety Intelligence.
Safety oversight goes beyond processing events — it requires interpretation, context, and timely action.
UNIQ provides experienced medical monitors and safety physicians who actively review emerging safety data in real time. By combining clinical expertise with structured analytics, we help sponsors distinguish true signals from background noise.
Our model supports continuous safety evaluation through proactive trend monitoring, protocol-specific risk assessment, and ongoing communication with sponsors and study teams.
This integrated approach allows potential issues to be identified and addressed early – before they escalate into protocol amendments, enrolment pauses, or regulatory concern.
Medical Monitoring & Signal Intelligence
From Individual Cases to Meaningful Safety Intelligence.
UNIQ delivers comprehensive pharmacovigilance support across the full product lifecycle — from early clinical development through post-approval safety oversight. Our global model combines centralized safety leadership with local expertise, ensuring compliance with regional requirements while maintaining consistent oversight and control.
We support sponsors across all development phases, including the establishment of pharmacovigilance systems required for marketing authorization, as well as the ongoing management of post-marketing safety activities in line with international regulatory standards.
Comprehensive Clinical Safety Operations
- Development and maintenance of Safety Management Plans
- Hosting and administration of validated safety databases, including legacy data migration
- End-to-end SAE intake, processing, medical review, and assessment
- Global safety reporting to health authorities, ethics committees, and investigative sites
- Ongoing safety data analysis and aggregate safety reports (DSURs, periodic outputs)
This approach ensures consistency, traceability, and inspection readiness across all studies.
Post-Approval & Market Expansion Safety Support
- Establishing new PV systems and quality documentation
- Preparing for marketing authorization and post-approval obligations
- Validated global safety database implementation
- Integration of safety data from clinical and post-marketing sources
- Expansion into EU, US, and APAC regions
Strategic PV consulting, SOP development, audits, and inspection-readiness training are also provided.
Centralized Global PV Operations
- Adverse event intake and case processing
- Expedited and aggregate safety reporting
- Regulatory database management (EudraVigilance, XEVMPD)
- Medical literature monitoring
- Risk management planning and ongoing surveillance
- PSURs, PBRERs, EU QPPV & PSMF support
- Safety automation deployment
Local & Affiliate Safety Services Worldwide
- Medical information & call center support
- Product quality complaint management
- Local case intake and processing
- Regional regulatory intelligence
- Local safety officers / QPPVs
- Country-specific RMPs & PSMFs
- Local risk minimization activities
Regulatory-Ready Pharmacovigilance & Compliance
Inspection-Ready Safety Systems Built for Global Compliance.
Global pharmacovigilance demands precision, traceability, and regulatory fluency.
UNIQ delivers safety operations aligned with ICH, EMA, FDA, MHRA, and regional requirements — ensuring consistent reporting, transparent documentation, and audit-ready processes at all times.
Our teams manage both expedited and aggregate reporting with disciplined timelines, clear accountability, and complete oversight — giving sponsors confidence in every submission and inspection.
Whether supporting IND-stage programs or marketed products, our pharmacovigilance framework is designed to scale without compromising control.
