Clinical & Regulatory Analyst
West Point, PA, US
1d ago
  • Assists the Clinical Safety and Risk Management team in the safety surveillance of assigned products. -Assists with data retrieval, data preparation, and analysis for, and quality assurance of, prepared responses to inquiries from health professionals, regulatory agencies and other customers regarding adverse experiences (AEs).
  • This includes contributing to the authoring of regulatory documents. -With guidance from the CSRM Associate, assists with the safety surveillance review of safety data such as adverse experience reports.
  • This is a Scientist position. -Bachelor’s degree required in nursing, pharmacy or other relevant health field plus 2 years of experience in clinical, pharmaceutical industry, or related field.
  • This position requires excellent writing and verbal communication skills, problem solving ability, and analytical skills.
  • Proficiency with Microsoft program package (Word, Excel, and Powerpoint) is required with data management, quality assurance, and compliance experience highly desirable -Previously authored PSURs, DSURs, or RMPs.
  • Any experience in drug safety is a plus
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