SOP for Pharmacovigilance System Maintenance Guidelines for Pharmacovigilance System Maintenance 1) Purpose The purpose of this SOP is to outline procedures for the ongoing maintenance and support of pharmacovigilance systems to ensure continuous functionality, data integrity, and compliance with regulatory requirements. 2) Scope This SOP applies to personnel responsible for pharmacovigilance system maintenance, including IT…

SOP for Pharmacovigilance System Validation Guidelines for Pharmacovigilance System Validation 1) Purpose The purpose of this SOP is to establish procedures for validating pharmacovigilance systems to ensure compliance with regulatory requirements and data integrity standards. 2) Scope This SOP applies to personnel responsible for pharmacovigilance system validation, including IT personnel, pharmacovigilance managers, and quality assurance…

SOP for Pharmacovigilance Safety Database Upgrades Guidelines for Pharmacovigilance Safety Database Upgrades 1) Purpose The purpose of this SOP is to define procedures for planning, executing, and validating upgrades to the pharmacovigilance safety database to enhance functionality, performance, and compliance. 2) Scope This SOP applies to personnel responsible for pharmacovigilance database management, including database administrators…

SOP for Pharmacovigilance Safety Database Lock Procedures Guidelines for Pharmacovigilance Safety Database Lock Procedures 1) Purpose The purpose of this SOP is to establish procedures for locking the pharmacovigilance safety database at predefined intervals to ensure data integrity and regulatory compliance. 2) Scope This SOP applies to personnel responsible for pharmacovigilance database management, including database…

SOP for Pharmacovigilance Aggregate Report Distribution Guidelines for Pharmacovigilance Aggregate Report Distribution 1) Purpose The purpose of this SOP is to define procedures for the distribution of pharmacovigilance aggregate reports to regulatory authorities, marketing authorization holders (MAHs), and other stakeholders in compliance with regulatory requirements. 2) Scope This SOP applies to personnel responsible for pharmacovigilance…

SOP for Pharmacovigilance Expedited Reporting Criteria Guidelines for Pharmacovigilance Expedited Reporting Criteria 1) Purpose The purpose of this SOP is to establish criteria and procedures for identifying and reporting expedited safety reports of suspected serious adverse reactions (SUSARs) to regulatory authorities within defined timelines. 2) Scope This SOP applies to personnel responsible for pharmacovigilance case…

SOP for Pharmacovigilance Causality Assessment Guidelines for Pharmacovigilance Causality Assessment 1) Purpose The purpose of this SOP is to establish procedures for conducting causality assessment of adverse events reported in pharmacovigilance to determine the likelihood of a causal relationship between medicinal products and adverse events. 2) Scope This SOP applies to personnel involved in pharmacovigilance…

SOP for Pharmacovigilance Seriousness Assessment Guidelines for Pharmacovigilance Seriousness Assessment 1) Purpose The purpose of this SOP is to provide guidelines for assessing the seriousness of adverse events reported in pharmacovigilance to determine appropriate regulatory reporting and risk management actions. 2) Scope This SOP applies to personnel responsible for pharmacovigilance case assessment and seriousness determination…

SOP for Pharmacovigilance Data Analysis and Reporting Guidelines for Pharmacovigilance Data Analysis and Reporting 1) Purpose The purpose of this SOP is to establish procedures for conducting pharmacovigilance data analysis and preparing accurate and timely safety reports to regulatory authorities and stakeholders. 2) Scope This SOP applies to personnel involved in pharmacovigilance data analysis, reporting,…

SOP for Pharmacovigilance Data Entry and Verification Guidelines for Pharmacovigilance Data Entry and Verification 1) Purpose The purpose of this SOP is to establish standardized procedures for accurate and timely data entry and verification in pharmacovigilance to ensure data quality and compliance with regulatory requirements. 2) Scope This SOP applies to personnel involved in pharmacovigilance…