The Role of SOPs in Pharmacovigilance


Mark Cooper

By 2016-12-02

Standard operating procedures (SOPs) are used in many industries but are particularly important in drug safety and pharmacovigilance. SOPs are essential for a successful global PV system.

Standard operating procedures (SOPs) are used in many industries but are particularly important in drug safety and pharmacovigilance. SOPs are essential for a successful global PV system. Pharmacovigilance standard operating procedures are a set of detailed written instructions that clearly define and standardize procedures to achieve quality, efficiency, and uniformity across all teams, while preventing errors, misinformation, waste, and rework.

Pharmacovigilance operates globally, which makes the need for standardization so important. Through establishing a systematic way of performing PV procedures, SOPs ensure all teams are on the same page and work is done consistently by everyone completing the same task. There is a specific SOP for each of the pharmacovigilance and drug safety processes, such as processing adverse events and SAEs, aggregate reporting, quality oversight of safety processes, signal detection, risk management, and regulatory intelligence. When SOPs are written, they must be reviewed for adequacy, completeness and compliance before they can be approved for release. SOPs are required to comply with all applicable laws, regulations and guidance’s, and must be reviewed and updated over their life cycle as required. Any changes made to the SOP must be re-approved.

At SJ Pharma Consulting, LLC, our pharmacovigilance consultants and experts have created a complete set of pharmacovigilance standard operating procedures. Our SOPs satisfy the requirements of the global PV system and have been utilized and updated over many years. They comply with the requirements of the most recent EV PV legislation. Countless pharmaceutical companies use our SOPs, which have passed regulatory inspections in the United States and Europe. View a complete list of our pharmacovigilance standard operating procedures.

For more information about standard operating procedures in pharmacovigilance and drug safety compliance, contact our pharmacovigilance consultants. SJ Pharma offers a variety of PV products and services to ensure your organization maintains the highest level of compliance and performance.