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.
Reporting to the Vaccine Safety Science Lead.
The Opportunity
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.
About You
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
Closing date for Applications: Friday 13th November
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.
About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.