Executive Level 1

2 weeks ago

Canberra, Australia National Health Funding Body Full time

**Job Reference Number **22-MRDIV-15752

**Classification **Executive Level 1

**Job Title **Professional Officer

**Division **Medicines Regulation Division

**Branch **Pharmacovigilance Branch

**Section **Medicine Shortages Section

**Location **Fairbarn, ACT

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$108,680 - $123,951

**Mandatory Qualifications **A degree in pharmacy, pharmacology, medicine, nursing,
pharmaceutical science, biology or other relevant science from
an Australian tertiary institution, or comparable overseas
qualifications.***

**Contact Officer Name**:Cath Brown
**Phone**:02 6289 3139

**Eligibility**
- To be eligible for employment with the Department of Health and Aged Care

applicants must be an Australian citizen at the time an offer of employment is made
- An applicant’s suitability for employment with Health will also be assessed through a

variety of pre-employment check processes, such as:

- Satisfactory completion of an Australian Federal Police criminal history check,

and where relevant a Working with Children and Vulnerable People Check.
- Completion of a medical declaration and pre-employment medical (where

required).
- Providing evidence of qualifications.

**Division Responsibilities**

The Therapeutic Goods Administration (TGA) is part of Australian Government Department

of Health and Aged Care and is responsible for safeguarding and enhancing the health of the

Australian community through the effective and timely administration of the Therapeutic

Goods Act 1989. The TGA's overall purpose is to protect public health and safety by

regulating therapeutic goods, such as medicines, medical devices, biologicals, human blood,

blood products and tissues.

The Medicines Regulation Division (MRD) is responsible for undertaking evaluations of

make decisions whether to approve or reject market authorisation of medicines that are

imported, exported, manufactured, and supplied in Australia. MRD also has responsibility

for ongoing monitoring of medicines approved for supply in Australia to ensure they

continue to maintain an appropriate level of quality, safety and efficacy following entry into

the Australian marketplace. The Division includes:

- Pharmacovigilance Branch (PB)
- Complementary and Over-the-counter Medicines Branch (COMB)
- Prescription Medicines Authorisation Branch (PMAB)
- Scientific Evaluation Branch (SEB)
- International Regulatory Branch (IRB)

**Branch Responsibilities**

The Pharmacovigilance Branch (PB) is responsible for post-market monitoring of medicines

and vaccines to ensure they continue to maintain an appropriate level of quality, safety and

efficacy following entry into the Australian marketplace along with the evaluation and

monitoring of Risk Management Plans for high-risk medicines. PB also oversees access to

products not on the Australian Register of Therapeutic Goods, but for which there is a

clinical need, through the various special access programmes and clinical trial schemes and

manages medicines shortages in Australia.

**Section Responsibilities**

The Medicine Shortages Section is responsible for the TGA's Medicine Shortages

Information Initiative and the Medicine Shortages Reports Database. We publish

information about shortages of prescription and some important over-the-counter

medicines and undertake management actions such as providing approval for supply of

alternative overseas-registered products. Team members process shortage notifications

from sponsors, undertake market assessments and work with other TGA staff to monitor

for, and mitigate the effects of, medicine shortages. The section is also responsible for

implementing a number of reforms to communication and education strategies, regulations

and legislation relevant to medicine shortages, business processes and data analytics.***

**Key Responsibilities**
- Make robust regulatory decisions and recommendations based on data,

research, critical evaluation, and sound judgement
- Supervise APS 6 staff within the Medicine Shortages Section and assist with

prioritisation and distribution of work
- Represent the TGA at cross-agency meetings, conferences, and other forums***
- Manage and lead coordination of specific high priority medicine shortages,

including recommending and implementing management actions, and

collaborating with key stakeholders
- Interpret data and contribute to leadership of the section’s data analytics

activities, including medicine supply modelling, signal detection and various

inputs to broader multi-departmental government initiatives.
- Leading liaison with and provide accurate advice to internal and external

stakeholders to assist with the management, mitigation, and prevention of

medicine shortages
- Play a leading role in strategic planning for the medicine shortages function***
- Engage with external stakeholders such as medicine sponsors, medical colleges,

professional societies, and consume

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