Details.
Management of local and global pharmacovigilance systems, support for clinical trials and post-marketing surveillance, vigilance requirements for devices, vaccines and medicines, end-to-end ISCR management, medical review, signal detection and aggregate report compilation, RMP and ASA development, safety database exchange agreements, sponsor representation as the health authority contact person and qualified person for pharmacovigilance in Australia and New Zealand, and inspection readiness activities including internal and partner pharmacovigilance audits.