SOP for Pharmacovigilance Adverse Event (AE) Reporting Guidelines for Pharmacovigilance Adverse Event (AE) Reporting 1) Purpose The purpose of this SOP is to outline procedures for the reporting of adverse events (AEs) associated with pharmaceutical products. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for AE reporting, including pharmacovigilance managers, safety scientists, and…

SOP for Pharmacovigilance Serious Adverse Event (SAE) Management Guidelines for Pharmacovigilance Serious Adverse Event (SAE) Management 1) Purpose The purpose of this SOP is to outline procedures for the management and reporting of serious adverse events (SAEs) related to pharmaceutical products. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for SAE management, including…

SOP for Pharmacovigilance Incident Management Guidelines for Pharmacovigilance Incident Management 1) Purpose The purpose of this SOP is to establish procedures for the management and reporting of pharmacovigilance incidents and non-serious adverse events. 2) Scope This SOP applies to all pharmacovigilance personnel involved in incident management, including pharmacovigilance managers, case managers, and safety scientists. 3)…

SOP for Pharmacovigilance Compliance Monitoring Guidelines for Pharmacovigilance Compliance Monitoring 1) Purpose The purpose of this SOP is to outline procedures for monitoring and ensuring compliance with pharmacovigilance regulations and guidelines. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for compliance monitoring, including pharmacovigilance managers, compliance officers, and quality assurance personnel. 3) Responsibilities…

SOP for Pharmacovigilance Post-Marketing Surveillance Guidelines for Pharmacovigilance Post-Marketing Surveillance 1) Purpose The purpose of this SOP is to establish procedures for conducting post-marketing surveillance (PMS) to monitor the safety of pharmaceutical products after they have been authorized for use. 2) Scope This SOP applies to all pharmacovigilance personnel involved in post-marketing surveillance activities, including…

SOP for Pharmacovigilance Risk Evaluation and Mitigation Strategy (REMS) Guidelines for Pharmacovigilance Risk Evaluation and Mitigation Strategy (REMS) 1) Purpose The purpose of this SOP is to outline procedures for developing and implementing Risk Evaluation and Mitigation Strategies (REMS) in pharmacovigilance. 2) Scope This SOP applies to all pharmacovigilance personnel involved in REMS development and…

SOP for Pharmacovigilance Inspection Readiness Guidelines for Pharmacovigilance Inspection Readiness 1) Purpose The purpose of this SOP is to establish procedures for ensuring pharmacovigilance activities are inspection-ready at all times. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for maintaining inspection readiness, including pharmacovigilance managers, quality assurance officers, and compliance specialists. 3) Responsibilities…

SOP for Pharmacovigilance Audit Preparation Guidelines for Pharmacovigilance Audit Preparation 1) Purpose The purpose of this SOP is to outline procedures for preparing pharmacovigilance activities and documentation for internal and external audits. 2) Scope This SOP applies to all pharmacovigilance personnel involved in audit preparation, including pharmacovigilance managers, quality assurance officers, and compliance specialists. 3)…

SOP for Pharmacovigilance Quality Control Checks Guidelines for Pharmacovigilance Quality Control Checks 1) Purpose The purpose of this SOP is to establish procedures for conducting quality control checks in pharmacovigilance to ensure data accuracy, completeness, and compliance with regulatory requirements. 2) Scope This SOP applies to all pharmacovigilance personnel involved in quality control checks, including…

SOP for Pharmacovigilance Medical Inquiry Response Guidelines for Pharmacovigilance Medical Inquiry Response 1) Purpose The purpose of this SOP is to establish standardized procedures for responding to medical inquiries related to pharmacovigilance. 2) Scope This SOP applies to all pharmacovigilance personnel involved in responding to medical inquiries, including medical information specialists, pharmacovigilance officers, and pharmacovigilance…