S & P Specialist

Job Requirements

• Knowledge of GCP and ICH guidelines preferred
• Drug development/clinical trial experience essential
• Knowledge of safety databases and/or MedDRA coding preferred
• Experience leading clinical and cross-functional teams is a plus
• Excellent oral, written, presentation and computer skills
• 2+ years of academic, pharmaceutical or biotech industry or academic experience

Responsibilities

• Ensures compliance with TRI Standard Operating Procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to regulatory agencies
• Develops and ensures the uniform and timely processing of adverse event reports
• Performs medical evaluation of adverse event reports
• Performs various tasks in support of clinical research including the 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
• Maintains/updates agent-specific clinical and preclinical toxicity study summary tables for investigational agents
• Performs literature searches
• Prepares 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
• Aids 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; prepares, reviews, and edits presentations regarding safety issues

Qualifications

Hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.