Responsibilities:
- 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.
- Responsible for supporting the GCSP with safety data analyses data retrieval from the GCSP safety database. Provide PL/SQL to analyses the safety database and/ or retrieve data as needed. In addition, other software tools will be used as appropriate. Contribute to the establishment of standard programs, standard procedures and work practices to ensure quality control and audit trails for analyses appropriate for regulatory submissions and publication.
- This role has global responsibilities with potential for matrix management , participation in global teams, and requires skills in leadership without formal authority.
Qualifications:
- Requires medical background with 3+ years' pharmaceutical experience.
- Previous experience and/or knowledge of Pharmacovigilance.
- Good understanding of medical terminology.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
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What We Do
CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.
Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.
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