Pharmacovigilence Specialist
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Make a Real Impact on Patient Safety
Fast-growing Australian pharmaceutical company - with Values-Driven Culture
Exciting new role to shape process and team success
Make a Real Impact on Patient Safety
Fast-growing Australian pharmaceutical company - with Values-Driven Culture
Exciting new role to shape process and team success
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