SOP for Pharmacovigilance Annual Safety Reports (ASR) Guidelines for Pharmacovigilance Annual Safety Reports (ASR) 1) Purpose The purpose of this SOP is to provide guidelines for the preparation, submission, and review of Annual Safety Reports (ASRs) in pharmacovigilance. 2) Scope This SOP applies to pharmacovigilance personnel responsible for the preparation, review, and submission of ASRs…

SOP for Pharmacovigilance Safety Data Monitoring Boards (DSMB) Guidelines for Pharmacovigilance Safety Data Monitoring Boards (DSMB) 1) Purpose The purpose of this SOP is to establish procedures for the operation and responsibilities of Safety Data Monitoring Boards (DSMBs) in pharmacovigilance. 2) Scope This SOP applies to DSMB members, pharmacovigilance personnel, and other stakeholders involved in…

SOP for Pharmacovigilance Compliance Monitoring Plan Guidelines for Pharmacovigilance Compliance Monitoring Plan 1) Purpose The purpose of this SOP is to outline procedures for monitoring pharmacovigilance activities to ensure compliance with regulatory requirements and internal standards. 2) Scope This SOP applies to pharmacovigilance personnel responsible for conducting compliance monitoring activities within the organization. 3) Responsibilities…

SOP for Pharmacovigilance Risk Assessment Tool Implementation Guidelines for Pharmacovigilance Risk Assessment Tool Implementation 1) Purpose The purpose of this SOP is to provide guidance on the implementation and use of risk assessment tools in pharmacovigilance to evaluate and manage risks associated with medicinal products. 2) Scope This SOP applies to pharmacovigilance personnel responsible for…

SOP for Pharmacovigilance Investigator Initiated Studies (IIS) Guidelines for Pharmacovigilance Investigator Initiated Studies (IIS) 1) Purpose The purpose of this SOP is to establish procedures for the management and pharmacovigilance oversight of Investigator Initiated Studies (IIS) conducted by external investigators. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for reviewing, monitoring, and reporting…

SOP for Pharmacovigilance Regulatory Intelligence Monitoring Guidelines for Pharmacovigilance Regulatory Intelligence Monitoring 1) Purpose The purpose of this SOP is to outline procedures for monitoring regulatory developments related to pharmacovigilance to ensure compliance with evolving regulations and guidelines. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for monitoring and interpreting regulatory intelligence, including…

SOP for Pharmacovigilance Stakeholder Communication Guidelines for Pharmacovigilance Stakeholder Communication 1) Purpose The purpose of this SOP is to establish procedures for effective communication with stakeholders involved in pharmacovigilance activities to ensure transparency, compliance, and timely exchange of information. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for communicating with internal and external…

SOP for Pharmacovigilance Contract Management Guidelines for Pharmacovigilance Contract Management 1) Purpose The purpose of this SOP is to establish procedures for the management of contracts related to pharmacovigilance activities, ensuring compliance with regulatory requirements and company policies. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the negotiation, execution, and management of…

SOP for Pharmacovigilance Vendor Management Guidelines for Managing Pharmacovigilance Vendors 1) Purpose The purpose of this SOP is to outline the procedures for selecting, qualifying, and managing vendors who provide services related to pharmacovigilance activities to ensure compliance with regulatory requirements and company standards. 2) Scope This SOP applies to all pharmacovigilance personnel involved in…

SOP for Pharmacovigilance Data Retention and Destruction Guidelines for Pharmacovigilance Data Retention and Destruction 1) Purpose The purpose of this SOP is to establish procedures for the retention and secure destruction of pharmacovigilance data in compliance with regulatory requirements and company policies. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the collection,…