Pharmacovigilance & Drug Safety
Zero Safety Gaps.
One PV Partner.
Every marketed product carries an ongoing safety obligation, and falling behind on it puts both patients and market authorization at risk. Our pharmacovigilance team manages the full spectrum of safety monitoring, so your products stay compliant from launch through the entire lifecycle.
24/7Case Intake
Overview
End-to-End PV Solutions
We support pharmacovigilance operations at any scale, from a single safety database to a fully outsourced global PV system.
Our processes are built around global reporting timelines and health authority expectations, reducing the risk of compliance gaps, missed deadlines, or inspection findings.
- ICSR case intake, triage, medical review and reporting
- Ongoing signal detection and evaluation
- PSUR, PBRER and DSUR aggregate reporting
- Risk Management Plans aligned to regional requirements
What We Deliver
ICSR, Signals & Aggregate Reports
The full spectrum of drug safety operations, delivered inspection-ready.
ICSR Processing
Case intake, triage, medical review, and regulatory reporting.
Signal Detection & Management
Ongoing safety signal identification and evaluation.
Aggregate Reporting
PSUR, PBRER, and DSUR preparation to global timelines.
Risk Management Plans
RMP development and maintenance aligned to regional requirements.
Safety Database Management
Setup, maintenance, and reconciliation of the safety database.
100%Reporting Compliance
5Global Regions
ISO9001:2015
24/7Case Intake
Our Approach
A PV System That Holds Up
Built around global reporting timelines and health-authority expectations.
01
Intake
Structured case intake and triage across every source.
02
Assess
Medical review, coding and causality assessment.
03
Report
Regulatory submission of ICSRs within required timelines.
04
Detect
Continuous signal detection and benefit-risk evaluation.
05
Aggregate
PSUR/PBRER/DSUR preparation and RMP maintenance.
Why Vigilare
Compliance & Risk Management
Pharmacovigilance built to withstand real inspection.
On-Time, Every Time
Processes engineered around global reporting deadlines to avoid compliance gaps.
Inspection-Ready by Design
Documentation and audit trails built for health-authority inspection.
Scales With You
From a single safety database to a fully outsourced global PV system.
Multi-Region Expertise
Reporting aligned to FDA, EMA and MHRA requirements simultaneously.
FAQs
Answered. Clearly.
01
What is pharmacovigilance?
Pharmacovigilance is the science of detecting, assessing, monitoring, and reporting adverse drug reactions to ensure patient safety throughout a product's lifecycle.
02
How does drug safety monitoring work?
Drug safety monitoring involves collecting adverse event reports, evaluating them for safety signals, and reporting findings to regulatory authorities within required timelines.
03
What is ICSR processing?
ICSR (Individual Case Safety Report) processing involves collecting, reviewing, and submitting reports of individual adverse events to relevant health authorities as required by pharmacovigilance regulations.
Related Services
Explore the Full Practice
Ready to outsource your PV operations?
Whether you need a single PSUR or a complete pharmacovigilance system, our team keeps you compliant from launch onward.