Safety of the drugs is one of the rising concern , hence pharmacovigilance Professionals play key role in safety monitoring of drugs . In this session we are going to learn about pharmacovigilance and its role in drug safety

 Pharmacovigilance Definition: As Per WHO definition  “the science and activities related to the detection, assessment, understanding and prevention of adverse drug effects or any other possible drug-related problems”

Goals of Pharmacovigilance

• To Promote safe use of medicines
• To ensure Patient Safety
• Post Marketing Surveillance

Responsibilities of Pharmacovigilance

Early Detection of Adverse Events : One of the important aspect of PV is early detection of Adverse events and this is achieved by identifying and evaluating adverse reactions associated with medicinal products , vaccines and biologics thereby minimizing the risks and enhancing patient safety.

Benefit-Risk Assessment: PV conducts rigorous assessment of risk-benefit profile of pharmaceutical products. For a drug to be safe the safety profile and therapeutic profile should be on the higher side and the therapeutic benefits vs potential risk data is sent to Regulatory authorities to make informed decision regarding medicine use

Strengthening Regulatory Compliance: Prompt reporting of safety concerns to regulatory authorities is prime task for PV . Adhering to regulatory guidelines to ensure compliance.

Post-Marketing Surveillance:   This comes under Phase-IV of clinical trails where effects of drug is monitored in large populations , Once the drug is released in the market , Safety monitoring is done through spontaneous reports and solicited reports.

Signal Detection and Evaluation: PV acts as a sensor, constantly sensing for potential safety signals amidst vast amounts of data. Identified signals undergo systemic evaluation to take further actions.