Summary
Overview
Work History
Education
Skills
Timeline
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Jean Crawford

Kansas City,MO

Summary

Dynamic Pharmacovigilance Advisor with a proven track record at Nostrum Laboratories Inc, adept at authoring SOPs and PVAs. Demonstrated exemplary communication and superb problem-solving skills while successfully navigating FDA audits. Authored comprehensive reports on ADEs/ADRs, ensuring compliance and enhancing risk management strategies.

Overview

12
12
years of professional experience

Work History

Pharmacovigilance Advisor

Nostrum Laboratories Inc
05.2013 - 04.2025
  • Authored and enacted Pharmacovigilance and Product Complaint/Inquiry standard operating procedures (SOPs)
  • Authored and enacted Pharmacovigilance Agreements (PVAs) between Nostrum and potential partners from the pharmaceutical industry
  • Also reviewed and edited preexisting PVAs when presented by potential partners
  • Classified incoming adverse drug experiences/adverse drug reactions (ADEs/ADRs) from all sources based upon seriousness and expectedness
  • Surveilled medical/scientific literature reports for serious and unexpected ADEs/ADRs associated with Nostrum ANDAs;wrote all reports and submitted to the FDA in accordance with their timelines
  • Trained selected personnel om the necessary steps to be taken while performing pharmacovigilance duties
  • Successfully navigated 5 FDA audits (2 audits were virtual)


Education

M.D. - Medicine

University of North Dakota School of Medicine
Grand Forks
05-1996

Skills

  • Exemplary communication skills
  • Thorough knowledge and use of the English language both written and spoken
  • Authored numerous reports concerning risk evaluation and mitigation strategies; ADEs/ADRs; statistical analysis; product complaints; etc
  • Superb assessment and problem solving skills

Timeline

Pharmacovigilance Advisor

Nostrum Laboratories Inc
05.2013 - 04.2025

M.D. - Medicine

University of North Dakota School of Medicine

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