Safety and Pharmacovigilance Specialist - USMD
Technical Resources International

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.

Job Requirements
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