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Safety and Pharmacovigilance Specialist - USMD job in Bethesda at Technical Resources International

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Safety and Pharmacovigilance Specialist - USMD at Technical Resources International

Safety and Pharmacovigilance Specialist - USMD

Technical Resources International Bethesda, MD Full Time

Responsibilities

Performs various tasks in support of clinical research including adverse event analysis and processing; serious adverse event reconciliation; preparation of IND safety reports for submission to the FDA; safety document or data analysis; clinical trial site support; reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development; assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labeling/package inserts, and other reports as necessary; may review experimental protocols and informed consent documents; and prepares, reviews, and edits presentations regarding safety issues. 

 

Requirements

  • M.D. from a U.S. accredited institution with active U.S. medical license required
  • Infectious disease and/or oncology subspecialty highly preferred
  • Knowledge of GCP and ICH guidelines preferred
  • Drug development/clinical trial experience essential
  • Knowledge of CTC and/or MedDRA coding preferred
  • Experience leading clinical and cross functional teams is a plus
  • Must have excellent oral, written, presentation and computer skills
  • 2+ years of pharmaceutical or biotech industry or academic experience

Recommended Skills

  • Administration
  • Provide Actionable Feedback
  • Communicate Regulatory Requirement
  • Support Regulatory Audits
  • Support Regulatory Filings
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Job ID: 217/114/552

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