Job Description

• Ensures compliance with 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 guidelines and ensures the uniform and timely processing of adverse event reports
• Acts as liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
• Develops and prepares reports for company management as well as external regulatory requirements
• Provides medical evaluation of adverse event reports
• Reviews experimental protocols and informed consent documents; prepares, reviews, and edits presentations regarding safety issues
• 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
• 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
• Assists in gathering adverse event report information documentation
• Maintains/updates agent-specific clinical and preclinical toxicity study summary tables for investigational agents
• Contributes to client proposals and responses to client questions
• Maintains files of publications relating to safety
• Suggests improvements to current procedures/processes
• Leads/coordinates client requests/projects
• Participates in the training and mentoring of staff.
• Participates in Business Development activities

• Experience in clinical research and drug safety
• Ability to analyze medical research data, review experimental protocols, and summarize safety data
• Excellent oral, written, and computer skills

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