General role description

Pharmacovigilance Scientists play a key role in monitoring the safety of medicines and medical devices after they have entered clinical trials or the market. They analyse safety data, investigate potential risks, and ensure that adverse events are reported and addressed according to regulatory standards.

This role suits detail-oriented professionals with a background in life sciences or health, and a strong interest in patient safety, data analysis, and regulatory affairs.

Key responsibilities

• Collect, review, and assess reports of adverse events or side effects associated with medicines or medical devices
• Analyse safety data from multiple sources, including individual case reports, clinical trial data, safety databases, and published literature, to identify potential risks or trends
• Ensure that all safety reports are submitted accurately and on time to regulators and other authorities
• Monitor global safety databases to identify potential safety signals or trends
• Prepare and review safety reports
• Work with medical reviewers and regulatory teams to evaluate whether new information changes the safety profile of a product
• Assist in the development and maintenance of standard operating procedures and pharmacovigilance systems
• Stay current with changes to Australian and international pharmacovigilance regulations, such as those from the Therapeutic Goods Administration (TGA), European Medicines Agency (EMA), and U.S. FDA
• Participate in regulatory audits or inspections (e.g. from the TGA or FDA), answer questions from auditors, and help address any findings or improvements identified during these reviews.