Leads, oversees and actively contributes to the development, implementation and maintenance of a robust safety reporting system compliant with current applicable regulations. This includes closely managing the PV vendor and the case workflow, reviewing samples of cases to ensure ICSR quality and compliance with regulatory timeframes.
Supports training the PV vendor on new products and compliance requirements.
Supports PV set up and implementation of new studies / programs, including interventional Clinical Trials and Post-authorisation safety studies.
Reviews and contributes to PV vendor operational documentation, e.g. operational plans, program specific work-instructions.
Oversees safety database configuration, ensuring it meets applicable regulations and program needs.
Ensures the quality, completeness and timeliness of delivery of all outputs from the safety database sup...