Director, Translational Development

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!

Responsibilities:
• Manages compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA), World Health Organization, country and regional regulations for the reporting of adverse events to regulatory agencies.
• Develops and implements pharmacovigilance guidelines and ensures the uniform and timely processing of adverse event data on all marketed products in development.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
• Develops and prepares reports for company management as well as external regulatory agencies.
• May provide medical evaluation of adverse event reports.
• Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary.
• May work with data management in the ongoing development and maintenance of databases.

Qualifications:
• Bachelor degree, Medical Documentation, or equivalent in a life science discipline
• 10+ years Pharmacovigilance experience in multinational pharmaceutical industry
• Expert knowledge of local/international regulations and PV processes
• Experience with regulatory inspections
• Experience in administration of complex data sets
• Experience in project-managing CAPA and SOP development
• Experience with relevant software applications