This pivotal role ensures the safety and efficacy of company’s pharmaceutical products across Australia and New Zealand. You’ll manage adverse event reporting, monitor safety data, and support compliance with regulatory requirements while promoting a strong culture of patient safety and continuous improvement.

ABOUT THE ROLE

Receive, assess, and report adverse events and product complaints in line with the company’s procedures and TGA/Medsafe regulations

Lead and maintain staff training and records for adverse event reporting

Prepare and submit accurate safety reports to regulatory authorities within required timelines

Liaise directly with TGA, Medsafe, and other relevant agencies

Analyse and interpret safety data to identify trends and recommend corrective actions

Maintain comprehensive, audit-ready pharmacovigilance documentation

Support internal and external audits, ensuring compliance with GVP guidelines

Provide expert pharmacovigilance advice and training to internal stakeholders

Review marketing materials and due diligence dossiers for regulatory compliance

Collaborate with Regulatory Affairs, Quality Assurance, and Medical Affairs to ensure a coordinated safety approach

Contribute to the ongoing improvement of pharmacovigilance systems and processes

ABOUT YOU

Bachelor’s degree in Pharmacy, Science, or a related field

Minimum 3 years’ experience in pharmacovigilance or drug safety within the pharmaceutical industry

Strong knowledge of TGA and Medsafe pharmacovigilance requirements

Proven ability to assess and report adverse drug reactions accurately

Excellent written and verbal communication skills

Strong analytical and problem-solving abilities

High attention to detail and the ability to work under pressure

Proficiency in pharmacovigilance databases and safety reporting systems

Effective time management and organisational skills

Experience collaborating with cross-functional teams