Regulatory Affairs And Patient Safety Associate
CurrentAssisted with the compilation, submission and management of applications to the Therapeutic Goods Administration for variations to prescription and OTC medicines.Reviewed promotional and non-promotional material for prescription and OTC medicines to ensure compliance with the Australian regulatory requirements.Developed adverse event assessment tools and performed reporting of adverse events to clients' Patient Safety department via the agreed processes, completely and accurately within… Show more Assisted with the compilation, submission and management of applications to the Therapeutic Goods Administration for variations to prescription and OTC medicines.Reviewed promotional and non-promotional material for prescription and OTC medicines to ensure compliance with the Australian regulatory requirements.Developed adverse event assessment tools and performed reporting of adverse events to clients' Patient Safety department via the agreed processes, completely and accurately within an agreed upon time frame using the form(s) or via an online patient safety reporting tool.Performed adverse event reconciliations for patient orientated programs and other programs and conducted source document verification according to clients' policies, procedures and required timelines.Conducted other non-scheduled/ad-hoc monitoring activities as required.Maintained currency of all required training. Show less