Aps Level 5

**Job Reference Number **22-MRDIV-15436

**Classification **APS Level 5

**Job Title **Administrative Officer

**Division **Medicines Regulation Division

**Branch **Pharmacovigilance Branch

**Section **Medicine Shortages Section

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$79,002 - $85,437

**Contact Officer Name**:Deborah Hay
**Phone**:02 6289 3281

**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 Medicines Shortages Section is responsible for the TGA's Medicines 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**

The key responsibilities of the role are to assist in the day-to-day management and co
- ordination of:
coordinating responses for more complex enquiries.
- General oversight of MSS business and internal management systems.
- Draft and maintain corporate documentation such as templates, standard operating

procedures, and risk plans, with oversight from more senior staff.
- Provide administrative support to pharmacists within the section, including meeting

organisation, agenda and minute preparation, and maintenance and monitoring of

shared inboxes.
- Gathering data, analysing information, generating reports, and undertaking

preliminary assessments of lower impact shortages.
- Flexibility in contributing to team goals and broader organisational objectives by

undertaking other tasks as required.***

**Key Capabilities**
- High-level written and verbal communication skills
- High-level interpersonal skills, including the ability to develop productive working

relationships with internal and external stakeholders
- Strong understanding of records management responsibilities and maintains

appropriate records to support decisions and recommendations.
- Demonstrated analytical and critical thinking skills.
- The ability to work flexibly in a high-pressure environment.
- Demonstrated ability to m