Job Title: Associate MDR/Vigilance Specialist Job ID: 16323 Location: 8200 Coral Sea Street NE, Mounds View, MN 55112 (Hybrid) Duration: 24 Months Shift: 9AM 3PM (M-F) Pay Range: $30-35/hr on W2 Job Description: Top 3 things the manager is looking for: - Medical Background and/ or experience working for medical device manufacturers.
- Cardiovascular experience would be beneficial
- Experience working in a very regulated work environment
Top 3 Tasks or Responsibilities in scope for this role: - Creating Regulatory Reporting on potential complaints regarding medical devices
- Project Support
- working collaboratively with the rest of the team
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 integrate 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.
Education Required: Undergraduate degree
Years Experience Required: 1-3 years minimum
Location: Mounds View, MN Onsite 2 3 days a week in office (Hybrid) Core hours are 9am 3pm M-F
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.
Specialist Career Stream: Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
Differentiating Factors Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Make minor changes in systems and processes to solve problems.
Communication and Influence: Communicates primarily with internal contacts within immediate group. Contact others to gather, confirm and convey information.
Leadership and Talent Management: N / A job at this level is focused on self-development.
Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A), 0 years of experience required.
Thank You Devyansh Sharma Associate Recruiter