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Associate MDR Specialist

2 months ago

mounds view, United States Planet Pharma Full time

Location: Mounds View, MN Onsite work Wednesday and Thursday.

Hours: 40


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 follow-up 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.


Must Have: Minimum Requirements

• Bachelors degree required