With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
For our Global Clinical Safety & Pharmacovigilance department we are looking for a
Clinical Safety Scientist (m/f/x) - R-125271
(Fulltime/ fixed term: 1 year)
The Clinical Safety Scientist is an integral member of the Global Clinical Safety and Pharmacovigilance Safety Sciences function and is a key contributor to the lifecycle risk management activities of CSL products.
Under general supervision, the Clinical Safety Scientist is responsible for conducting integrated safety surveillance, review, analysis of relevant clinical safety data of CSL medicines throughout their lifecycle, that is, for products in clinical development and CSL manufactured products on the market in collaboration with the Clinical Safety Physician.
Main Responsibilities and Accountabilities:
Support Clinical Safety Physicians in the safety review process and evaluation of safety data throughout the product lifecycle using a combination of quantitative and qualitative approaches
Undertake signal detection activities on safety data sets from various sources, such as spontaneous adverse event listings, clinical trial datasets, reports or datasets from observational studies- and present summaries of the data in a meaningful way
Review publications from the scientific and medical literature for important safety information; summarise and critically appraise the findings from these publications for safety reports (such as periodic safety update reports, signal detection reports, signal evaluations)
Drafting of safety-related documents, particularly sections relating to safety risk management e.g. periodic safety update reports, development safety update reports, clinical overview addenda to support registration activities; and contributing to/ reviewing safety sections of other clinical or regulatory documents including Investigator’s brochures and submission dossiers
Risk Management Activities: Contribute to the production of, and updates to, Risk Management Plans for CSL manufactured products, including drafting of the safety sections.
Support ongoing risk management activities by participation in and coordination of the operational and scientific activities associated with internal cross-functional Safety Management Teams for the associated products.
Participate in associated development teams, such as the Study Execution Team and the Clinical Development Team, in collaboration with the Clinical Safety Physician.
Support the physician in providing responses for safety-related questions from internal sources and/or external regulatory requests
Contribute to quality improvement: Review, prepare, and/or update local and global SOPs and working instructions as required.
Experience in the following areas is an advantage:
Understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines and standards.
Knowledge and experience of safety monitoring and signal detection preferred.
Understanding of ICH GCP and drug development preferred
Qualifications & Experience:
A University Degree in a relevant field of Science (e.g. Biomedicine, Pharmaceutical Science)
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