Associate MDR/Vigilance Specialist Job at Planet Pharma, Minnesota

QjR5UXEycExBVCtQUWZJakR4VGF5RWo3K0E9PQ==
  • Planet Pharma
  • Minnesota

Job Description

GREAT OPPORTUNITY FOR FRESH GRADS TO GAIN EXPERIENCE WITH A GLOBAL INDUSTRY LEADING MEDICAL DEVICE COMPANY!

Top 3 things the manager is looking for in a candidates experience:

  1. strong attention to detail
  2. strong analytical skills (problem solving, critical thinking)
  3. strong writings skills

What are the top 3 Tasks or Responsibilities in scope for this role:

  1. document and evaluate product feedback and product analysis results for company products to determine complaint status
  2. compile regulatory agency reports for submission
  3. monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation

Education Required: Bachelor’s

Years’ Experience Required: a few months-2 years’ experience. Prefer some job experience but open to interviewing recent graduates.

In this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for company products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. In conjunction with US and OUS regulatory reporting criteria, the Associate MDR/Vigilance Specialist compiles regulatory agency reports for submission. As part of complaint closure activities this individual performs activities to monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation, and any associated follow-up actions that pertain to complaint closure.

Responsibilities include the following but not limited to:

• Apply policies and procedures to comply with FDA and OUS regulations.

• Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.

• Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.

• Ensures complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.

Job Tags

Similar Jobs

Apex Foundation Specialists

Outside Sales Consultant Job at Apex Foundation Specialists

 ...Outside Sales / Project Consultant Florida Panhandle Were a small, locally owned foundation repair company thats growing fast and were looking for someone to grow with us. We need an Outside Sales / Project Consultant to meet with homeowners, figure out... 

Guthrie

Maintenance Tech- Plant Services-Per Diem Job at Guthrie

 ...Under the direction of a Supervisor or his/her designees, the Maintenance Technician performs a variety of maintenance and engineering...  ...maintaining, repairing, operating, and renovating plant and facilities for the Engineering Department. Incumbent is guided by a basic... 

WHSP Medical, P.C.

Licensed Mental Health Clinician - Athletes & Sports Medicine Job at WHSP Medical, P.C.

 ...and regularly assess progress. Maintain timely and accurate clinical documentation in accordance with agency and licensing...  ...Engage in ongoing professional development related to sport psychology, eating disorders, and best practices in athlete mental health... 

Zora Real Estate Investments

Social Media Manager Job at Zora Real Estate Investments

 ...Social Media Manager responsible for developing and executing a multi-platform social media strategy for a Gen Zfocused, multi-disciplinary real estate brokerage. This role involves the consistent creation, curation, and posting of original content across all major platforms... 

Indiana Health Care Association

RN - Home Health Job at Indiana Health Care Association

We are seeking a dedicated RN - Home Health in Downey, CA, offering $3,439/week. Responsibilities Include Providing personalized in-home nursing care to patients Assessing patient conditions and developing care plans Administering medications and treatments...