SOP for Pharmacovigilance Clinical Trials Safety Reporting Guidelines for Pharmacovigilance Clinical Trials Safety Reporting 1) Purpose The purpose of this SOP is to outline procedures for the monitoring, evaluation, and reporting of safety data during clinical trials to ensure participant safety and regulatory compliance. 2) Scope This SOP applies to personnel involved in pharmacovigilance activities…

SOP for Pharmacovigilance Risk Management Activities Guidelines for Pharmacovigilance Risk Management Activities 1) Purpose The purpose of this SOP is to establish procedures for the identification, assessment, and management of risks associated with pharmaceutical products throughout their lifecycle. 2) Scope This SOP applies to personnel involved in pharmacovigilance risk management, including pharmacovigilance officers, risk managers,…

SOP for Pharmacovigilance Safety Signal Investigation Guidelines for Pharmacovigilance Safety Signal Investigation 1) Purpose The purpose of this SOP is to outline procedures for the investigation and evaluation of safety signals identified during pharmacovigilance activities. 2) Scope This SOP applies to personnel involved in pharmacovigilance signal detection, including pharmacovigilance officers, safety scientists, medical reviewers, and…

SOP for Pharmacovigilance Medical Device Reporting Guidelines for Pharmacovigilance Medical Device Reporting 1) Purpose The purpose of this SOP is to establish procedures for reporting adverse events associated with medical devices in compliance with regulatory requirements. 2) Scope This SOP applies to personnel involved in pharmacovigilance activities related to medical devices, including pharmacovigilance officers, medical…

SOP for Pharmacovigilance International Conference on Harmonization (ICH) Guidelines Compliance Guidelines for Pharmacovigilance ICH Guidelines Compliance 1) Purpose The purpose of this SOP is to ensure compliance with International Conference on Harmonization (ICH) guidelines related to pharmacovigilance activities, including safety reporting, risk management, and regulatory submissions. 2) Scope This SOP applies to personnel involved in…

SOP for Pharmacovigilance Medical Dictionary for Regulatory Activities (MedDRA) Coding Guidelines for Pharmacovigilance MedDRA Coding 1) Purpose The purpose of this SOP is to establish standardized procedures for the coding of adverse events and medical conditions using the Medical Dictionary for Regulatory Activities (MedDRA) terminology in pharmacovigilance. 2) Scope This SOP applies to personnel responsible…

SOP for Pharmacovigilance Database Query Management Guidelines for Pharmacovigilance Database Query Management 1) Purpose The purpose of this SOP is to establish procedures for managing queries in the pharmacovigilance database to ensure accurate and timely data retrieval for safety assessment and regulatory reporting. 2) Scope This SOP applies to personnel responsible for querying pharmacovigilance databases,…

SOP for Pharmacovigilance Signal Evaluation and Prioritization Guidelines for Pharmacovigilance Signal Evaluation and Prioritization 1) Purpose The purpose of this SOP is to define procedures for the systematic evaluation, prioritization, and management of pharmacovigilance signals to ensure timely identification and assessment of potential safety concerns. 2) Scope This SOP applies to personnel involved in pharmacovigilance…

SOP for Pharmacovigilance Aggregate Report Approval Guidelines for Pharmacovigilance Aggregate Report Approval 1) Purpose The purpose of this SOP is to establish procedures for the review, approval, and submission of pharmacovigilance aggregate reports to regulatory authorities. 2) Scope This SOP applies to personnel responsible for reviewing and approving pharmacovigilance aggregate reports, including pharmacovigilance managers, medical…

SOP for Pharmacovigilance Case Narratives Review Guidelines for Pharmacovigilance Case Narratives Review 1) Purpose The purpose of this SOP is to define procedures for reviewing and assessing pharmacovigilance case narratives to ensure accuracy, completeness, and compliance with regulatory requirements. 2) Scope This SOP applies to personnel responsible for reviewing pharmacovigilance case narratives, including pharmacovigilance scientists,…