Senior Pharmacovigilance Scientist (f/m/d) in Melbourne

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.

Qualifications:

• Bachelor’s or equivalent degree (depending on national educational system) required in the pharmaceutical, nursing or biological sciences (Degree in Medicine and Pharmacy is preferred).
• 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.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

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.