Summary

CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.

Job description

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, or 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

Requirements

Bachelor's or equivalent degree in pharmaceutical, nursing, biological, or sciences (Medicine and Pharmacy 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
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 in a cross functional environment

Company overview

CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.