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Safety and Pharmacovigilance Specialist job in Bethesda at Technical Resources International

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Safety and Pharmacovigilance Specialist at Technical Resources International

Safety and Pharmacovigilance Specialist

Technical Resources International Bethesda, MD Full-Time


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. 



M.D. or D.O. from an accredited institution or RN, PhD, PharmD, or MPH with direct Drug Safety experience, 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

  • Biotechnology
  • Clinical Research
  • Clinical Trials
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  • Data Analysis
  • Drug Development
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Job ID: 62/92/806

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