Technical Resources International, Inc.

Responsibilities:

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 technical proposals and responses to technical 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

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Job Snapshot

Employee Type Full-Time

Location Bethesda, MD

Job Type Biotech

Experience Not Specified

Date Posted 06/28/2022

Job ID 419/142/807