EMPLOYMENT

We are looking for an enthusiastic Medical Officers with strong written communication skills and a focus on high quality evaluation of medical evidence. These Medical Officers will work in a dynamic team and contribute to important pharmacovigilance work at the Therapeutic Goods Administration. The key duties of the position include Branch-wide responsibilities include: • Contributing to the provision of high quality medical/clinical advice on regulatory issues within the TGA. • Undertaking analysis and interpretation of evidence and applying judgement in choosing a course of action to manage complex and/or sensitive issues. • Under broad direction, working with autonomy in decision-making and exercising astute judgement and a high level of discretion. • Synthesising in-depth medical knowledge with knowledge of relevant departmental policies and regulatory requirements and applying this across a number of issues. • With limited direction, negotiating and liaising with internal and external stakeholders in relation to a range of matters, including representing the Department and the TGA at meetings and conferences as required. • Maintaining communication and negotiating with overseas drug regulatory agencies, the World Health Organization, medical and allied professions, the pharmaceutical industry, and hospital authorities on matters relating to medicines and vaccines. • Contributing to the development and revision of technical and administrative procedures, documentation, SOPs, policy development, new work process reforms in order to efficiently and effectively undertake claims scheme responsibilities. • Managing and organising work in the context of sensitive issues, competing priorities and conflicting interests including appropriately escalating complexities and/or seeking advice on issues where required. • Developing and maintaining a good understanding of the Australian regulatory environment for therapeutic products. • Supervising and/or mentoring staff as required, including leading, co-ordinating and managing workflow. • Maintaining professional knowledge and skills in accordance with Australian Health Practitioner Regulation Agency (Ahpra) registration requirements. • Attending relevant training sessions for medical and scientific staff at the TGA. • Assisting the Director with other tasks as required. In addition, specifically for the Medicines Surveillance and Signal Investigation Section (MSSIS): • Applying public health, technical and clinical expertise to detect and investigate post-market safety issues for medicines, with reference to the appropriate legislation and policy frameworks. • Preparing high quality written reports detailing the outcome of investigations and and making appropriate recommendations. In addition, specifically, for COVID-19 Vaccine Claims Assessment Section (CVCAS): The Medical Officer Level 2 and 3 are key members of CVCAS; they support the Section by providing day to day technical and specialist advice or expertise which includes but is not limited to: • Undertaking evaluation (critical assessment) of complex submissions of medical evidence against pre-agreed criteria and providing recommendations to Services Australia. • Preparing concise written reports detailing the outcome of the evaluation and analysis and detailing recommendations in a logical and scientific manner.