Senior Pharmacovigilance Scientist in Melbourne

At CSL, patient safety is at the heart of everything we do. We're seeking a Senior Pharmacovigilance Scientist to join our Global Safety & Pharmacovigilance team, where you'll play a critical role in monitoring, evaluating, and managing the safety profile of our products across their entire lifecycle.

Working closely with cross-functional global teams, you'll contribute to safety surveillance activities, signal detection, risk management, and regulatory reporting that help ensure the safe and effective use of CSL medicines worldwide.

As a Senior Pharmacovigilance Scientist, you will support the ongoing assessment of clinical and post-marketing safety data, providing scientific expertise to inform benefit-risk evaluations and regulatory decision-making. You'll collaborate with Global Safety Leads and stakeholders across Development, Medical Affairs, Regulatory Affairs, and Clinical teams to support product safety strategies and risk management activities.

Key Responsibilities

• Lead the safety review process and evaluation of safety data throughout the product lifecycle using a combination of quantitative and qualitative approaches, in partnership with the Global Safety Lead (GSL).
• Perform end to end signal detection and analysis activities on safety data sets from various sources, and present summaries of the data in a meaningful way.
• Review publications from the scientific and medical literature for important safety information for further use in various analyses or aggregate safety reports (ASRs).
• Provide strategic input and/or contributions to various ASRs (Periodic Safety Update Reports, Development Safety Update Reports, PADERs, Risk Management Plans etc.).
• Organize and provide key insight to internal cross functional Safety Management Teams (SMTs).
• Support product development teams (such as the Study Execution Team and the Clinical Development Teams) with PV related expertise relating to clinical data.
• Develop response strategy and perform required analyses for any safety-related questions from internal sources and/or external regulatory requests.
• Mentor more junior members of the PVS community, including assisting with on-boarding and providing advice on day-to-day tasks.
• Other Activities as required, including but not limited to: case adjudication, review of key clinical documents (IBs, CSRs, etc), support in SOP updates, subject matter expert support for dedicated PVS activities, etc.

You are a scientifically minded pharmacovigilance professional with strong analytical skills and a passion for patient safety. You thrive in a collaborative environment, enjoy solving complex problems, and can confidently communicate scientific information to a variety of stakeholders.

Qualifications, Skills & Experience

• Bachelor’s or equivalent degree (depending on national educational system) required in the pharmaceutical, nursing or biological, or sciences. Degree in Medicine and Pharmacy is preferred.
• 7+ years' Pharmacovigilance experience in multinational pharmaceutical industry with at least 3 years’ experience as a Pharmacovigilance scientist or equivalent position in a closely related discipline.
• Understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines, and standards.
• Ability to provide solutions for issues/challenges that may arise during the course of a project.
• Knowledge and experience of safety monitoring and signal detection preferred.
• Understanding of ICH GCP and drug development preferred.
• Computer proficiency in basic database entry and graphics presentations (e.g., Microsoft Excel or equivalent).
• Excellent written and verbal communication skills in English, with the ability to evaluate, interpret and synthesize scientific data.
• Self-motivated, able to prioritize and plan effectively.
• Ability to work independently and as a team player, working in a cross functional environment.

This position is ideally based in Melbourne Australia; however, suitably qualified candidates in Zurich Switzerland, Maidenhead UK and King of Prussia are encouraged to apply.