Global Medical Safety Scientist - Fordyce, AR, United States - Velocity Ventures

James Miller

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James Miller

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Freelance
Description

Your Role in Fordyce, AR:


  • Conduct preliminary assessments and medical reviews in Argus Safety as a CSR
  • Contribute to relevant medical safety sections in Aggregate Safety Reports (PSURs, DSURs, etc.)
  • Assist in developing and maintaining Risk Management Plans
  • Create and maintain a list of safety concerns
  • Perform signal detection and assess safety signals
  • Serve as a safety expert in the development and maintenance of product information (IB, CCDS, local/region labels)
  • Evaluate, review, and approve safety findings from literature
  • Prepare responses to safety inquiries from internal and external stakeholders
  • Collaborate on the preparation of safety materials for internal and external safety and labeling boards
  • Manage and assess discrepancies in SAE reconciliation and provide medical safety input for resolution

What We Are Looking For:


  • Medical Doctor with previous clinical experience (preferred)
  • Strong organizational skills to thrive in a large corporate matrix environment
  • Experience working crossfunctionally and internationally
  • At least 35 years of experience in a similar role in the pharmaceutical industry or CRO (Oncology experience preferred)
  • Familiarity with safety databases, specifically Argus Safety
  • Proficiency in Microsoft Office, including PowerPoint and Excel
  • Excellent project and time management skills
  • Demonstrated leadership abilities with a proactive and strategic mindset
  • Fluent in written and spoken English

What We Offer:


  • A modern workplace and exciting opportunities in a fast

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