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Drug Safety Physician

Company: Ascent
Location: Pleasanton
Posted on: November 11, 2019

Job Description:

Drug Safety Physician?Pleasonton, CA?

  • Heavily integrated into the ICSR workflow to provide Medical Review.? Medical review will include verifying accuracy of previously entered assessments, creating a Company comment, and an analysis of Similar Events
  • Execute the Signal management process including detection, evaluation and communication of additional risk minimization measures. ?A candidate for this role will be able to present patient data in the context of the Clinical Trial and make recommendations to the Executive Safety Advisory Committee
  • Leads Investigator Brochure development for safety sections including Reference Safety Information.? This may involve responding to Regulatory Agency requests.?
  • Interact with Drug Safety Operations for: training opportunities identified, ensuring compliance within work flow, continuous quality improvement (CQI), and other areas as needed
  • Participate in cross functional monitoring of the study data with Medical Monitors, Biostatistics and Executive Director of Drug Safety
  • Be a lead for one or more molecule in development and support clinical study team on safety issues, IB, DSUR, protocol, ICF, CSR, case reviews etc.
  • Contribute to clinical trial protocols, IND/NDA submissions and Risk Management Plans
  • Assist in the preparation of aggregate reports and other safety related documents or section that may include: DSURs, 6-month line listings, internal safety assessment reports
    • Develop materials and conduct training sessions when appropriate to a variety of audiences
      • Ability to assign priority within a clinical development environment at all phases of multiple programs. ?Qualifications:
        • MD or equivalent medical training.? Should have at least 2 years of clinical experience, post-residency (internal medicine, HemOnc, immunology perferred) and at least 3 years of experience in Drug Safety/Pharmacovigilance
        • Must have worked in pharmaceutical company as a Director or above in drug safety
        • Expert knowledge of FDA CFR, ICH and clinical development programs is required.? Preferably working knowledge of EMA GVP and CIOMS.
        • Drug safety surveillance experience in oncology/hematology preferred
        • Experience providing Drug Safety support for clinical development programs in a cross functional collaborative manner?
        • Ability to interpret related regulatory guidance and problem solve towards a compliance approach with a background and understanding of industry best practices?
        • Working knowledge of MedDRA coding and its appropriate use in data mining
        • Demonstrated ability to establish and meet priorities, deadlines, strategic department goals, and objectives
        • Medical writing experience required?
        • Ability to work efficiently and effectively with minimal supervision
        • Ability to mentor and couch staff, supervisory experience preferred.
        • Excellent collaboration and communication skills is required with the ability to present information to a wide range of audiences.?

          Company Description:

          About Ascent:Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent---s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.If you are ready to propel your career to new heights--- read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

Keywords: Ascent, San Francisco , Drug Safety Physician, Other , Pleasanton, California

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