Senior Pharmacovigilance Scientist – Vaccines, Global Safety

CSL; Melbourne; On-site; AUD 150,000 - 210,000; Full time

Job summary

CSL in Melbourne, Australia, is seeking a Senior Pharmacovigilance Scientist to join our Global Safety & Pharmacovigilance team. You will monitor, evaluate, and manage the safety profile of CSL medicines across their lifecycle, collaborating with Development, Medical Affairs, Regulatory, and Clinical teams to support safety strategies and risk management.

You will lead safety reviews, perform end-to-end signal detection, review literature for safety information, contribute to ASRs and risk

Qualifications

• 7+ years of Pharmacovigilance experience in a multinational pharmaceutical company.
• ≥3 years as a PV scientist or equivalent.
• Knowledge of pharmacovigilance methodologies and global safety regulations (ICH GCP).
• Excellent written and verbal English communication.

Responsibilities

• Lead safety review processes and evaluate data across the product lifecycle with the Global Safety Lead.
• Perform end-to-end signal detection and analysis on safety data sets and present summaries.
• Review publications for important safety information for use in analyses and reports.
• Contribute to Periodic Safety Update Reports, Development Safety Update Reports, PADERs, and Risk Management Plans.
• Organize insights for cross-functional Safety Management Teams.
• Support development teams with PV expertise relating to clinical data.
• Develop response strategies for safety-related questions from internal/external sources.
• Mentor junior PV team members and assist with onboarding.
• Handle ad hoc activities like case adjudication and SOP updates.

Skills

Analytical skills

Communication

Team collaboration

Independence

Education

Bachelor’s degree in pharmaceutical/biological sciences

Medicine and Pharmacy degree preferred

Tools

MS Excel

Job description

CSL in Melbourne, Australia, is seeking a Senior Pharmacovigilance Scientist to join our Global Safety & Pharmacovigilance team. You will monitor, evaluate, and manage the safety profile of CSL medicines across their lifecycle, collaborating with Development, Medical Affairs, Regulatory, and Clinical teams to support safety strategies and risk management.

You will lead safety reviews, perform end-to-end signal detection, review literature for safety information, contribute to ASRs and risk