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. 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.