New college grads are acceptable
Responsibilities may include the following and other duties may be assigned.
Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and followup on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries. Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.