SOP for Pharmacovigilance Aggregate Report Writing Guidelines for Writing Pharmacovigilance Aggregate Reports 1) Purpose The purpose of this SOP is to establish standardized procedures for writing pharmacovigilance aggregate reports to…
SOP for Pharmacovigilance Periodic Reporting Guidelines for Periodic Pharmacovigilance Reporting 1) Purpose The purpose of this SOP is to establish standardized procedures for the preparation and submission of periodic safety…
SOP for Pharmacovigilance Expedited Reporting Guidelines for Expedited Pharmacovigilance Reporting 1) Purpose The purpose of this SOP is to establish standardized procedures for expedited reporting of serious adverse events (SAEs)…
SOP for Pharmacovigilance Data Entry Guidelines for Entering Pharmacovigilance Data 1) Purpose The purpose of this SOP is to establish standardized procedures for entering pharmacovigilance data to ensure accuracy, consistency,…
SOP for Pharmacovigilance Follow-up Procedures Guidelines for Pharmacovigilance Follow-up Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting follow-up activities for pharmacovigilance cases to…
SOP for Pharmacovigilance Case Narrative Writing Guidelines for Writing Pharmacovigilance Case Narratives 1) Purpose The purpose of this SOP is to establish standardized procedures for writing case narratives in pharmacovigilance…
SOP for Pharmacovigilance Case Assessment Guidelines for Assessing Pharmacovigilance Cases 1) Purpose The purpose of this SOP is to establish procedures for the assessment of pharmacovigilance cases to ensure accurate…
SOP for Pharmacovigilance Case Intake Guidelines for Intake of Pharmacovigilance Cases 1) Purpose The purpose of this SOP is to establish standardized procedures for the intake of pharmacovigilance cases to…
SOP for Pharmacovigilance Case Processing Guidelines for Processing Pharmacovigilance Cases 1) Purpose The purpose of this SOP is to define the procedures for processing pharmacovigilance cases to ensure timely and…
SOP for Pharmacovigilance Database Management Guidelines for Managing Pharmacovigilance Databases 1) Purpose The purpose of this SOP is to define the procedures for managing pharmacovigilance databases to ensure data integrity,…