Standard Operating Procedures in Pharmacovigilance

Updated

February 16, 2023

Standard Operating Procedures (SOPs) in pharmacovigilance are detailed written instructions that
outline the steps and processes involved in specific pharmacovigilance activities. SOPs are used to
ensure consistent and uniform performance of pharmacovigilance activities, and to ensure that these
activities are performed in compliance with regulatory requirements and industry standards.

SOPs in pharmacovigilance typically cover areas such as:

Adverse event reporting and processing, including procedures for receiving, documenting, and triaging
adverse event reports.

Risk management activities, such as procedures for conducting risk assessments and implementing risk
minimization measures.

Data management, including procedures for storing, maintaining, and retrieving pharmacovigilance
data.

Literature searches and other forms of safety surveillance, including procedures for conducting
literature searches, monitoring the safety literature, and assessing the impact of new safety information.

Communication with regulatory agencies and other stakeholders, including procedures for
communicating safety information to healthcare providers, patients, and the public.

SOPs play a critical role in ensuring that pharmacovigilance activities are performed consistently and
efficiently, and that they are in compliance with regulatory requirements and industry standards. SOPs
help to ensure that the safety of medical products is continuously monitored and evaluated, and that
patients are protected by the safe and effective use of these products.