Introduction:
Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a vital role in ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle — from clinical trials to post-marketing surveillance.
With the increasing complexity of drug development and global regulatory requirements, pharmacovigilance has become a critical function in safeguarding public health. It supports informed decision-making by healthcare professionals, regulatory authorities, and pharmaceutical companies regarding the use of medicinal products.
The primary objectives of pharmacovigilance include:
- Identifying previously unrecognized adverse drug reactions (ADRs)
- Monitoring changes in the frequency or severity of known ADRs
- Ensuring that the benefits of a drug outweigh its risks
- Promoting safe and rational use of medicines
Global regulations — such as ICH E2E, GVP (Good Pharmacovigilance Practices), and FDA/EMA guidelines — form the framework for PV systems, emphasizing continuous monitoring, data analysis, and risk mitigation strategies.
Pharmacovigilance not only helps protect patient safety but also enhances trust in pharmaceutical systems and supports regulatory compliance in an increasingly risk-conscious healthcare environment.
- SOP for Search and Review of Global Medical Literature and Digital Media to Identify adverse events and Safety Data
- SOP for Handling of Adverse events and Safety Information
- SOP for Handling of Medical Inquiries
- SOP for Safety Data Exchange Agreements
- SOP for Communication of Safety Concerns to Consumers HCP’s and Regulatory Authorities
- SOP for Implementation of Safety Variations in Product’s Labeling Documents
- SOP for Risk Management Plan
- SOP for Periodic Safety Update Report (PSUR)
- SOP for Signal Management
- SOP for Pharmacovigilance Audit & Inspection Readiness
- SOP for Pharmacovigilance System Master File (PVMF)