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Assoc MDR/Vigilance Spec

Saint Paul, MN 55112

Posted: 12/05/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 592601 Is job remote?: No Country: United States

Job Description


Top 3 things the manager is looking for: 
  1. MDR Experience
  2. Previous healthcare experience
  3. Med device company experience

Top 3 Tasks in Scope for this role: 
  1. Review incoming complaints from the field
  2. Go back out to the field for further information on complaints
  3. 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

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 Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Saint Paul, MN

Explore exciting job opportunities in the vibrant area around Saint Paul, Minnesota! Known as the 'Twin Cities' area along with Minneapolis, Saint Paul offers a dynamic job market with ample room for growth and development. Considered the state capital, Saint Paul boasts a unique blend of historic charm and modern amenities. From the iconic Cathedral of Saint Paul to the bustling Saint Paul Farmers Market, there is always something to discover in this culturally rich city. With renowned art galleries like the Minnesota Museum of American Art, world-class theaters such as the historic Fitzgerald Theater, and beloved sports teams like the Minnesota Wild hockey team calling the Xcel Energy Center home, there's no shortage of entertainment options. Embrace the Midwest's warm hospitality and endless outdoor activities in beautiful parks like Como Park and the Mississippi River trails. Let's kickstart your career in this thriving and enchanting region – browse our job listings today!

Although this hasn't been an issue at Planet Pharma, 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 Planet Pharma.