Pharmacovigilance & Drug Safety Operations
Comprehensive lifecycle safety monitoring, signal detection, and regulatory compliance across 62 countries. Aevum Zenth maintains WHO-GVP and ICH-certified pharmacovigilance systems supporting over 140 marketed medicines and clinical trial programs.
Program Overview
Aevum Zenth’s Pharmacovigilance division operates as an integrated, end-to-end drug safety ecosystem. Our mandate encompasses the continuous monitoring of medicinal product safety throughout the entire lifecycle—from preclinical development through post-marketing surveillance. We maintain a fully qualified Pharmacovigilance System Master File (PSMF) and execute rigorous Risk Management Plans (RMPs) aligned with global best practices.
Our operations are structured around three core pillars:
- Case Processing & Management: 24/7 intake and processing of spontaneous reports, literature findings, and clinical trial adverse events with strict adherence to regulatory timelines.
- Signal Detection & Risk Evaluation: Proactive mining of aggregated safety databases using quantitative and qualitative methodologies to identify emerging safety concerns.
- Quality Assurance & Auditing: Independent internal audits, vendor oversight, and continuous process improvement validated through annual QPPV (Qualified Person for Pharmacovigilance) reviews.
Regulatory Framework & Compliance
All pharmacovigilance activities are conducted under strict compliance with international standards, including ICH E2A–E2F, WHO-GVP modules, EU Directive 2001/83/EC, and 21 CFR Part 312. Our regional compliance teams maintain direct regulatory liaison channels to ensure real-time alignment with evolving guidance.
Global Safety Network
Our distributed pharmacovigilance infrastructure ensures uninterrupted case processing and regulatory reporting across all time zones. Regional safety centers handle localization, medical translation, and authority submissions while centralized analytics teams manage global signal detection.
- Americas Hub (New York): Primary FDA reporting, US spontaneous intake, and aggregate safety report preparation.
- EMEA Hub (Dublin): EMA liaison, PSUR/PBRER drafting, EU-GVP implementation, and QPPV oversight.
- APAC Hub (Singapore): NMPA/PMDA submissions, Asian clinical trial safety monitoring, and regional literature scanning.
- Global Safety Operations Center (Geneva): 24/7 case triage, expedited reporting coordination, and crisis management.
AI & Data Infrastructure
Aevum Zenth leverages proprietary and enterprise-grade pharmacovigilance technology to accelerate case processing, enhance data quality, and enable predictive safety analytics.
Natural Language Processing (NLP)
Automated extraction and coding of adverse events, concomitant medications, and product names from unstructured spontaneous reports and medical literature.
Real-World Evidence Integration
Continuous ingestion of EHR data, claims databases, and patient registries to support comparative effectiveness and post-marketing safety surveillance.
Blockchain Audit Trails
Immutable logging of all case creation, modification, and submission events to ensure full regulatory transparency and data integrity compliance.
Predictive Signal Analytics
Machine learning models trained on historical safety data to prioritize emerging signals and optimize resource allocation for risk evaluation.
Submission & Reporting Standards
All regulatory submissions adhere to ICH E2B(R3) XML standards and are transmitted via validated direct electronic submission pathways. Aggregate reports are prepared under EU-ARIANE/WHO-ART frameworks.
| Report Type | Timeline | Format / Standard | Automation Level |
|---|---|---|---|
| Expedited (Individual Case) | 7–15 days post-detection | E2B(R3) XML / CIOMS | 98% Automated |
| PSUR / PBRER | Quarterly / Annual / Development | E2C(R2) / EU-ARIANE | Draft Auto-Generated |
| Deviance Reports | Within 14 days of deviation | Regulatory Template | Manual Review |
| Literature Findings | Continuous / Monthly Batch | E2B(R3) / MEDDRA | NLP-Assisted |
Safety Reporting & Inquiries
Healthcare professionals, patients, and regulatory authorities can submit adverse event reports or request pharmacovigilance documentation through the channels below. All submissions are triaged by licensed clinical pharmacovigilance associates.