|Job Type:||Full Time|
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!
Located in Parkville (Australia), Amsterdam (Netherlands), or Maidenhead (UK), a fixed term (12 months) full time role has become available.
Reporting to the Head of Safety Sciences, you will contribute to the conduct of integrated safety surveillance via the review and analysis of relevant safety data of Seqirus medicines throughout their lifecycle. This includes both products in clinical development and marketed products and involves working in collaboration with the responsible Safety Physician.
- Contribute to the development of clinical study documents and clinical submissions. Perform signal detection activities for assigned products. Assist in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labelling/package inserts and other reports as necessary.
- Develop and prepare reports, including Risk Management Plans and aggregate reports, for company management as well as external regulatory agencies.
- Support risk management operations, including signal detection and management, ongoing review of literature and compilation and interpretation of safety data to support product strategies
- Ensure compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations
Tertiary qualified in biological science, allied medical discipline or pharmacy, preferably with a Masters or PhD and complementary experience in a pharmaceutical/biotechnology industry
- A minimum of 8 years Pharmacovigilance experience in multinational pharmaceutical industry, including support of clinical development programs
- Expert knowledge of local/international regulations and PV processes
- Experience with regulatory inspections and CAPA and SOP development
- Experience with relevant software applications (Office applications, statistical software) and in administration of complex data sets
- Strong customer focus
- Demonstrated ability to work autonomously to achieve goals and communicate effectively within a cross functional environment
- Highly developed organisation skills including planning and time management
Job ref R-123390 . Closing date for applications Thursday 22nd October 2020