Clinical Safety Scientist/Senior Clinical Safety Scientist (pharmacovigilance).
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 one of the largest influenza vaccine companies 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!
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.
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.
Responsibilities and Accountabilities:
1 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.
2 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. Lead analysis strategy for signal evaluations and advise on additional required analysis for signal detection.
3 Review publications from the scientific and medical literature for important safety information; summarize and critically appraise the findings from these publications for safety reports (such as periodic safety update reports, signal detection reports, signal evaluations).
4 Provide strategic input or oversight and contribute individual safety relevant key sections for the preparation of aggregate safety reports (Periodic Safety Update Reports, Development Safety Update Reports, PADERs etc.) according to agreed processes and timelines. In collaboration with aggregate reporting/safety medical writing, ensuring cross-functional discussion and contribution to the report strategy and preparation. Ensuring that the contents of the report reflect the ongoing safety activities for the product.
5 Lead the preparation of sections of risk management plans and aggregate reports assigned to the Clinical Safety Scientist/Clinical Safety Physician, and assist the Clinical Safety Physician with the governance approval of the contents of these plans.
6 Lead (in collaboration with the Clinical Safety Physician), or play a key role in, internal cross functional Safety Management Teams and contribution to the risk management plans for the associated products, as well as coordinating the operational activities associated with the team. Participate in associated development teams, such as the Study Execution Team and the Clinical Development Team, in collaboration with the Clinical Safety Physician.
Qualifications and Experience Requirements:
- Bachelor’s or equivalent degree (depending on national educational system) required in the biological, nursing, or pharmaceutical sciences.
- Advanced clinical/scientific degree preferred.
- At least 3 years’ experience as a clinical safety scientist or 5 years' experience for a Senior Clinical Safety Scientist role.
- Understanding of pharmacovigilance and global clinical safety methodology and regulations.
- Experience with leading preparation/authoring/providing strategic input for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
- Performing and/or leading aggregate safety analysis and case level reviews.
- Contributing member of multidisciplinary team and comfort collaborating with other functional experts for safety monitoring and risk management.
- Initiating/conducting/overseeing searches of internal and external databases and performing related signal detection.
- Some experience working on both development and post-marketed products is desirable.