Associate MDR / Vigilance Specialist

Job Title - Associate MDR / Vigilance Specialist Exempt - 11589

Number of Positions 2
Job Location - Mounds View, Minnesota 55112. On site 2 days per week
Job Start Date - 11/13/23
Job End Date - 11/11/24
Education Required: Bachelor's degree
HM's Top Needs:

1. Strong attention to detail
2. Strong analytical skills (problem solving critical thinking)
3. Strong writing skills

*Any type of health care professional experience is helpful.

Responsibilities for this role include:

• Reviewing product events from a variety of sources to determine the complaint status and create the complaint record in the complaint handling system.
• This role is also responsible for determining the regulatory reporting status, completing the regulatory report, and ensuring timely submission.
• Responsibilities of this role also include conducting follow-up with internal and external contacts to ensure complete complaint information is obtained as well as evaluating incoming information for Medical Device Reporting and Vigilance Reporting eligibility.
• 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.