Executive Level 1
7 days ago
Executive Level 1
- $116,418 - $132,777
- Fairbairn ACT, Brisbane QLD, Melbourne VIC
Do you enjoy leading a team and improving work processes to investigate and develop solutions to complex problems?
Do you want a role where you collaborate with colleagues and no day is the same?
Then this is the role for you The Recalls Section’s primary function is to coordinate and manage recall and non-recall actions for therapeutic goods in Australia as per the Uniform Recall Procedure for Therapeutic Goods (URPTG). This involves liaison with the sponsor/supplier of the therapeutic good and the relevant regulatory area/s within the TGA. The outcomes of these interactions may result in a market action (recall/non-recall) or referral to another stakeholder, internal or external to the TGA.
Recalls are undertaken to resolve an anomaly with therapeutic goods for which there are established deficiencies in quality, efficacy, safety, presentation or performance. A therapeutic goods recall may also be initiated following a request by the TGA or as a result of reports referred from a variety of sources.
Team members collect and collate information to make risk-based assessments as part of their role in managing and coordinating recall and non-recall actions. Recommendations are made to identify and implement appropriate responses or recall activities. Post-implementation, recall activities are monitored for compliance and effectiveness.
The Section is also overseeing the continuation of projects identified as part of the Recall Reforms Program and will also undertake further reform projects which will emerge in the future, including further recall process improvements, additional IT enhancements and the recalls digital transformation.
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