Establishment and configuration of dedicated drug safety mailboxes for efficient intake and management of safety information.
Continuous monitoring of safety mailboxes to ensure timely receipt and processing of adverse event reports and regulatory communications.
Systematic intake, triage, and prioritization of safety cases to support rapid and accurate case processing.
Ensuring mailbox management processes meet global regulatory requirements and audit standards.
Implementation of robust security measures to protect sensitive safety data and ensure confidentiality.
Seamless integration of mailbox management with pharmacovigilance databases and workflow tools.
Comprehensive documentation and audit trails for all mailbox activities to support compliance and inspections.
Ongoing training and support for mailbox users to ensure best practices and continuous improvement.