Safety and Pharmacovigilance

Our patient-first approach includes an emphasis on adverse reaction monitoring and reporting, which is critical to ensuring patient safety, data integrity and regulatory compliance. Our dedicated Safety team will oversee the preparation and review of the safety narrative and CIOMS documentation for adverse events, including serious adverse event, reporting. The robust management of safety information collected for new and approved therapeutic goods is not only a regulatory requirement, it is also vital for gaining detailed insights into a product’s potential adverse event knowledge. New data relating to the safety of an investigational treatment also helps to shape future research. Following marketing approval, maintaining the collection and evaluation of important data guides any changes to the safety profile.

Management, collection and reporting:

• Individual case safety report (ICSR) collection
• Medical review of ICSR and signal detection
• Risk Management Plan and Australian Specific Annex preparation
• Ongoing literature review and monitoring
• Development of safety data exchange agreement