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� 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
� 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
Full Time
$73k-90k (estimate)
05/25/2023
06/18/2024
The job skills required for MEDICAL MONITOR include Standard Operating Procedures, Presentation, etc. Having related job skills and expertise will give you an advantage when applying to be a MEDICAL MONITOR. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by MEDICAL MONITOR. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for MEDICAL MONITOR positions, which can be used as a reference in future career path planning. As a MEDICAL MONITOR, it can be promoted into senior positions as a Drug Safety/Medical Information Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary MEDICAL MONITOR. You can explore the career advancement for a MEDICAL MONITOR below and select your interested title to get hiring information.