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Company: CSL Behring
Location: King Of Prussia
Posted on: September 18, 2023

Job Description:

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and 30,000 employees worldwide, CSL is inspired 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, CSL Plasma, CSL Seqirus and CSL Vifor. 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.Could you be our next Head of Clinical Safety Scientist? This position is located in our King of Prussia PA, Marburg Germany or Melbourne Australia. It is a Hybrid role. You will report to the Executive Director, Head of Safety Sciences.The Senior Director, Head of Clinical Safety Scientists position is located within CSL's GCSP department and has global responsibility for managing clinical safety scientists across the entire portfolio of CSL products, from early phase development to post-marketing, and inclusive of all therapeutic areas. This includes activities that ensure the ongoing monitoring and proactive risk management of CSLBs products, by signal detection, safety data analysis/review and global literature screening.You will have strategic partnership with signal detection and management experts including performing signal detection, data mining and signal evaluation methodologies, that contribute to the growing knowledge base for the safety profile of CSLBs products. Responsibilities:Oversight and strategic management of the Clinical Safety Scientists function across all core sites globally (on therapeutically-aligned teams within United States, Germany and Australia, and other locations): Forms, aligns, empowers, and develops a global team of specialized safety scientist and signal management experts around a clear set of standards and strategic goals.Integrated Safety Surveillance: You will oversee the work of the clinical safety scientist team regarding integrated safety surveillance, review, analysis of relevant aggregate clinical safety data of CSLB medicines through their lifecycle; and generation of high quality outputs.Provides management and direction to the Principal Clinical Safety Scientists to ensure the ongoing development and competency of the clinical safety scientist function.Explores and Implements Approaches for structured assessment of safety data for both marketed products and for products in development, collaborating with signal detection experts and data retrieval and data science experts, considering tools, methods, and approaches for synthesis, display, and presentation of safety data.Inspection readiness: ensures inspection readiness of CSLB's global signal management system; assign appropriate experts within GCSP to be interviewed in regulatory inspections.Oversee Vendor Management Strategy and takes leadership in managing the model and approach to use and assessment of vendors supporting the functional area.Qualifications:

  • Minimum of Bachelor's (or international equivalent) in science, medicine/health sciences, pharmacy, or epidemiology. Masters is advantageous.
  • 10+ years Pharmacovigilance experience in multinational pharmaceutical industry, of which at least five (5) are in a safety sciences related role, with oversight of safety sciences fields and experience in signal detection and risk management across multiple therapeutic areas
  • Previous line or complex matrix management experience and a record of accomplishments in managing, training, and developing people
  • Experience of local/international regulations and PV processes for marketed products as well as those in development, including EU CTR
  • Experience serving as an SME in regulatory inspections
  • Experience in project-managing CAPA and SOP developmentBENEFITS
    • Medical, Dental Vision
    • 401K
    • Paid time Off Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.Please take the time to review our benefits site to see what's available to you as a CSL employee. 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!

Keywords: CSL Behring, Philadelphia , Bioinformatics, Other , King Of Prussia, Pennsylvania

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