Pharmacovigilance — IDDCR Global Research
Pharmacovigilance
Comprehensive safety data management and regulatory compliance.
IDDCR provides end-to-end pharmacovigilance services — from individual case safety report processing through aggregate reporting and signal detection — ensuring patient safety and regulatory compliance throughout the product lifecycle.
Our Approach to Pharmacovigilance
Our pharmacovigilance team delivers rigorous safety data management and regulatory reporting services aligned to ICH E2 guidelines and global regulatory requirements. We support sponsors across clinical development and post-marketing phases, providing the expertise and processes needed to maintain a robust pharmacovigilance system.
Core Capabilities
ICSR Processing & Reporting
Individual case safety report intake, medical review, causality assessment, MedDRA coding and expedited reporting to regulatory authorities within required timelines.
Aggregate Safety Reporting
DSUR, PSUR/PBRER, PADER and CIOMS II line listing preparation, with medical writing support for aggregate safety report narratives.
Signal Detection & Management
Systematic signal detection using quantitative and qualitative methods, signal evaluation, risk characterisation and benefit-risk assessment.
Safety Database Management
Safety database setup, maintenance and validation in Argus Safety and Oracle AERS, with data migration and reconciliation support.
Risk Management
REMS/RMP development, implementation and effectiveness evaluation, with regulatory agency interaction support.
PV Audits & Inspections
PV system audit support, inspection readiness preparation, CAPA management and regulatory authority inspection support.
Therapeutic Areas
Development Phases
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Frequently Asked Questions
Common questions about this service — answered by our specialist team.
Need Pharmacovigilance Support?
Speak with our PV team about your safety data management, aggregate reporting and signal detection requirements.