Assoc MDR/Vigilance Spec
8200 Coral Sea Street Northeast Saint Paul, MN 55112 US
Top 3 things the manager is looking for:
- MDR Experience
- Previous healthcare experience
- Med device company experience
Top 3 Tasks in Scope for this role:
- Review incoming complaints from the field
- Go back out to the field for further information on complaints
- File regulatory reports
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
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.