Patient Safety Associate

at  BI Australia

THE POSITION

Reporting to the Head of Patient Safety, AUNZ , we have an exciting opportunity for a full-time Patient Safety Associate based in Sydney to join our high performing team!
This role will require team contribution to ensure a compliant local pharmacovigilance (PV) system which supports patient safety and public health in Australia and New Zealand.

REQUIREMENTS

• Pharmacy, pharmacology, medical science, or similar background.
• Patient Safety & Pharmacovigilance experience is not required but desirable.
• Experience communicating with patients and/or healthcare professionals desirable.
• Clear written communication skills with attention to detail.
• Team and collaborative focus with a compliance mindset.
• Ability to contribute towards efficient and streamlined processes.

• Report and submit Individual Case Safety Report (ICSR) in line with internal processes and Australian and New Zealand regulatory requirements using the global safety database.
• Contribute to the quality of the local Pharmacovigilance (PV) system by executing tasks in line with internal processes and timelines, with clear and concise documentation.
• Contribute towards inspection and audit-readiness, including detection of quality improvements and timely implementation of CAPAs.
• Ensure customer focused communication of queries concerning case information are communicated to reporters (including patients, prescribers, pharmacists, and study coordinators) within the valid BI Timelines and properly document in Global Safety Platform.
• Create and support the implementation of activities to enhance local Patient Safety culture and awareness at local level of the organisation.
• Screen local scientific literature for identification of PV relevant information.
• Prepare local Australian-specific annex to the Risk Management Plan in liaison with local cross functional colleagues.
• Contribute towards the safety information within local Product Information and Consumer Medicine information documents.
• Support the Head of Patient Safety by promptly alerting to relevant safety concerns as well as contributing towards the optimisation of local processes.