Aps Level 5

**Job Reference Number **23-MRDIV-16639

**Classification **APS Level 5

**Job Title **Policy Analyst

**Division **Medicines Regulation Division

**Branch **Pharmacovigilance Branch

**Section **Risk Management Section

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

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

**Contact Officer Name**:Iga Policinska
**Phone**:02 6289 2454

**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

Senior managers in the MRD 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) oversees the critical function of ensuring that medicines

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

Australian marketplace. PB also 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 and undertake other high profile

projects.

**Section Responsibilities**

The Risk Management Section (RMS) has a number of functions and responsibilities

including:

- Evaluating RMPs for selected prescription medicines and biologicals, negotiating

changes to these plans and monitoring sponsor’s compliance with their risk

management commitments***
- Evaluating Periodic Safety Update Reports, and safety summaries for prescription

medicines and biologicals***
- Administering the clinical trial access schemes***
- Delivering the Pharmacovigilance Inspection Program (PVIP) and***
- Delivering the Good Clinical Practice Inspection Program (GCPIP)***

**Key Responsibilities**

Key responsibilities are to assist in the day-to-day management and coordination of:
systems.***
- Action, respond to and investigate complex IT issues to ensure ongoing functioning
- Gathering data, analysing information, generating reports on clinical trials.***
- Draft, implement and maintain corporate documents such as standard operating

procedures, templates, and rosters relevant to the team and the section, with

oversight from more senior staff.***

forms relevant to clinical trials.***
- Provide administrative support within the team and supervise more junior

administrative staff, as required.***
- Liaise with internal and external stakeholders to resolve complex/sensitive issues

and complaints.
- Provide high quality customer service and maintain good stakeholder relationships.***
- Undertake an active role supporting the development and implementation of a

assisting with functional specifications to meet the organisation’s needs.***
- Contribute to innovating CT administrative procedures and strategic planning.***

**Key Capabilities**
- understanding of relevant legislation, guidance material and standard operating

procedures
***
- excellent organisational skills and the ability to manage competing priorities***
- demonstrated use of sound judgement and problem-solving skills***

issues
***
- attention to detail and organisational skills***
- high-level communication and interpersonal skills, including the ability to maintain

positive working relationships, and to build collaborative working relationships with
internal and external stakeholders***
- ability to work collaboratively an