Job Role Overview
The Medical Officer role is pivotal in ensuring the quality, safety and efficacy of medicines supplied in Australia. This position involves making informed decisions regarding market authorisation of medicines.
Key Responsibilities
* Overseeing the Medicines Regulation Division to guarantee compliance with regulatory standards.
* Assessing and approving or rejecting applications for medicinal products.
* Collaborating with the Pharmacovigilance Branch to ensure medicines meet quality and safety standards.
Divisional Roles
The MRD plays a critical role in ensuring the Australian market has access to safe and effective medicines.
They oversee decision-making processes related to medicinal product authorisation, importation, exportation, manufacturing and supply.
Branch Functions
The PB oversees the critical function of ensuring that medicines maintain an appropriate level of quality, safety and efficacy following entry into the Australian marketplace.
Additionally, they manage medicine shortages, oversee access to therapeutic products for clinical trials, run inspection programs focused on Good Clinical Practice and compliance with sponsors' pharmacovigilance obligations.
Sectional Responsibilities
The COVID-19 Vaccine Claims Assessment Section (CVCAS) is responsible for assessing medical information submitted under the COVID-19 Vaccine Claims Scheme.
This scheme provides assistance to individuals who suffer moderate to severe harm following adverse reactions to TGA-approved COVID-19 vaccines.