Pharmacovigilance (PV) plays a critical role in protecting patient safety throughout the lifecycle of medicinal products. As regulatory expectations continue to evolve globally, organisations must adopt proactive, robust, and compliant pharmacovigilance systems to effectively identify, assess, and manage safety risks.
In 2025, pharmacovigilance is no longer a reactive function—it is a strategic pillar of clinical development and post-marketing compliance.
What Is Pharmacovigilance?
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Its primary objective is to ensure that the benefit–risk balance of medicines remains favourable for patients.
PV activities span across:
- Clinical trials
- Post-marketing surveillance
- Real-world evidence generation
- Regulatory compliance and reporting
Key Components of an Effective Pharmacovigilance System
A compliant and efficient PV system includes several core elements:
-
1. Adverse Event (AE) & ICSR Management
Accurate and timely collection, triage, processing, and reporting of Individual Case Safety Reports (ICSRs) is fundamental. High-quality case processing ensures regulatory timelines are met and supports meaningful safety analysis.
-
2. Signal Detection & Risk Management
Continuous monitoring of safety data—including spontaneous reports, literature, and clinical data—is essential for identifying emerging safety signals. Risk Management Plans (RMPs) and mitigation strategies must be regularly reviewed and updated.
-
3. Aggregate Reporting
Regulatory authorities require periodic safety evaluations such as PSURs/PBRERs, which provide a comprehensive assessment of cumulative safety data and ongoing benefit–risk evaluation.
-
4. Literature Surveillance
Systematic screening of biomedical literature remains a regulatory requirement to capture unreported adverse events and safety information relevant to marketed products.
-
5. Pharmacovigilance System Oversight
Maintenance of the Pharmacovigilance System Master File (PSMF), SOPs, training records, audits, and quality management processes ensures inspection readiness and regulatory compliance.
Emerging Trends in Pharmacovigilance
-
Increased Regulatory Scrutiny
Authorities such as TGA, FDA, EMA, and Medsafe are strengthening expectations around data quality, signal management, and inspection readiness.
-
Integration of Real-World Evidence (RWE)
Real-world data from registries, electronic health records, and patient-reported outcomes is increasingly used to complement traditional safety data.
-
Automation & Digital Transformation
Advanced safety databases, workflow automation, and AI-assisted signal detection are improving efficiency and accuracy in PV operations.
-
Medical Device & Combination Product Vigilance
With regulations like EU MDR, post-market surveillance and vigilance requirements for medical devices have significantly expanded, requiring specialised expertise.
Why Pharmacovigilance Matters More Than Ever
A strong pharmacovigilance framework:
- Protects patients and public health
- Ensures regulatory compliance
- Supports successful product approvals and lifecycle management
- Reduces regulatory and reputational risk
- Builds trust with regulators, healthcare professionals, and patients
Organisations that invest early in robust PV systems are better positioned to manage safety risks and adapt to regulatory change.
How Nexus Pharma Group Supports Pharmacovigilance Excellence
At Nexus Pharma Group, we provide tailored pharmacovigilance consulting services across clinical development and post-marketing phases, including:
- ICSR processing and quality review
- Signal detection and safety evaluation
- PSUR / PBRER preparation and review
- Risk Management Plans (RMPs)
- Literature surveillance
- PSMF development and maintenance
- SOPs, training, and audit support
- Global regulatory compliance (TGA, FDA, EMA)
Our approach is grounded in scientific rigor, regulatory expertise, and a strong commitment to patient safety.