Benefits Opportunity to take on the role of Drug Safety Controller for Australia and New Zealand. Very competitive hourly rate. Work within a highly collaborative global pharmacovigilance team, supported by a network of experienced professionals. About the Company
This leading global biopharmaceutical company is renowned for its commitment to patient safety and regulatory excellence. With a strong focus on innovation and adherence to the highest standards of pharmacovigilance, the company has consistently advanced the field of drug safety, ensuring the well-being of patients worldwide. Their dedication to quality and compliance drives continuous improvements in safety monitoring, making them a trusted leader in the industry.
About the Opportunity
As the Drug Safety Controller, you will be instrumental in maintaining and enhancing the pharmacovigilance operations across Australia and New Zealand. Your role will involve the preparation of key regulatory reports, timely handling of safety information, and ongoing surveillance of regulatory updates. Your expertise will ensure the highest standards of safety are met, and you will play a crucial part in the submission of Significant Safety Issues (SSI) and the management of Organized Data Collection Systems (ODCS). Through your efforts, you will contribute to the safeguarding of public health by ensuring compliance with local and global safety regulations.
Please note, the first 3 months of this contract will be full-time hours per week for training purposes. After this point, the role will be moved to 20 hours per week on a casual basis. Responsibilities Deputy Safety Officer: Act as the Deputy Safety Officer for Australia and New Zealand in the absence of the Regional Safety Officer (RSO). Regulatory Reporting: Prepare quarterly reports for the Qualified Person Responsible for Pharmacovigilance (PV) in Australia. Adverse Event Management: Ensure timely forwarding of Adverse Event reports and safety information related to ANZ products. Regulatory Intelligence: Conduct surveillance of ANZ PV guidelines, webpages, and publications for updates. Skills and Experience Required Demonstrated experience in pharmacovigilance or related safety roles. Strong understanding of ANZ regulatory requirements and PV guidelines. Proven ability to manage safety reporting, regulatory submissions, and compliance activities. Advanced health sciences degree (Masters, MD, MBBS, PhD) preferred. Culture
The company fosters a culture of excellence, collaboration, and continuous learning. With a strong focus on patient safety and regulatory compliance, they provide an environment where professionals can thrive and contribute to the ongoing advancement of pharmacovigilance practices.
How to Apply
To express your interest, please contact Rohan at #J-18808-Ljbffr
