About The Position
CSL is seeking a Senior Pharmacovigilance Scientist to join its Global Safety & Pharmacovigilance team. The role monitors, evaluates, and manages the safety profile of products throughout their lifecycle, contributing to safety surveillance, signal detection, risk management, and regulatory reporting. The position supports assessment of clinical and post-marketing safety data and provides scientific expertise for benefit-risk evaluations and regulatory decision-making. It collaborates with Global Safety Leads and stakeholders in Development, Medical Affairs, Regulatory Affairs, and Clinical teams to advance product safety strategies and risk management activities. The role reports to the Vaccine Safety Science Lead. It is ideally based in Melbourne, Australia, with suitably qualified candidates in Zurich, Switzerland; Maidenhead, UK; and King of Prussia also encouraged to apply.
Requirements
- Bachelor’s degree or equivalent in pharmaceutical, nursing, biological, or other sciences.
- At least 7 years of pharmacovigilance experience in the multinational pharmaceutical industry, including at least 3 years as a Pharmacovigilance Scientist or equivalent in a closely related discipline.
- Understanding of pharmacovigilance and global clinical safety methodology, regulations, guidelines, and standards.
- Ability to provide solutions to issues and challenges that may arise during a project.
- Computer proficiency in basic database entry and graphics presentations, such as Microsoft Excel or equivalent.
- Excellent written and verbal communication skills in English, with ability to evaluate, interpret, and synthesize scientific data.
- Self-motivated, with the ability to prioritize and plan effectively.
- Ability to work independently and as a team member in a cross-functional environment.
Nice To Haves
- A degree in Medicine or Pharmacy is preferred.
- Knowledge and experience in safety monitoring and signal detection.
- Understanding of ICH GCP and drug development.
Responsibilities
- Lead the safety review process and evaluate safety data throughout the product lifecycle using quantitative and qualitative approaches in partnership with the Global Safety Lead.
- Perform end-to-end signal detection and analysis on safety data from various sources, and present meaningful summaries.
- Review scientific and medical literature for important safety information for analyses and aggregate safety reports.
- Provide strategic input and contributions to aggregate safety reports, including Periodic Safety Update Reports, Development Safety Update Reports, PADERs, and Risk Management Plans.
- Organize and provide insights to internal cross-functional Safety Management Teams.
- Support product development teams, including Study Execution and Clinical Development teams, with pharmacovigilance expertise related to clinical data.
- Develop response strategies and perform analyses for safety-related questions from internal sources and external regulatory requests.
- Mentor junior members of the Pharmacovigilance and Safety community, including supporting onboarding and providing day-to-day advice.
- Perform other activities as required, including case adjudication, review of key clinical documents such as IBs and CSRs, support for SOP updates, and subject matter expert support for dedicated Pharmacovigilance and Safety activities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
