Associate MDR/Vigilance Specialist Job at Planet Pharma, Minnesota

ZFdPWGU4TGNlV3hIYTBvOWRjWU5lZnZaRUE9PQ==
  • 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

Invisible North

Senior Account Manager Job at Invisible North

 ...headquartered in NYC with global reach. We are a team of culturally fluent account experts, strategists, creatives, designers, and producers...  ...bring brands to life. We are looking for a Senior Account Manager based in our NYC office to lead and orchestrate the of... 

TraxNYC Corp

High-End Jewelry Showroom Associate Job at TraxNYC Corp

 ...our social media below Instagram: TikTok: YouTube: Facebook: Twitter/X: Job Type: Full-time Pay: $18.00 - $25.00 per hour Expected hours: 40 50 per week Benefits: Employee discount Paid time off Ability to Commute: ~ New York... 

Veta Virtual

Bookkeeper - Property Management (HOA) Job at Veta Virtual

 ...Take Your Bookkeeping Career to the Next Levelwith Veta Virtual! Are you detail-focused, organized, and energized by the financial operations behind complex real estate portfolios? Veta Virtual is hiring a Bookkeeper Property Management (HOA) to support a fast-growing... 

Skechers

Application Security Engineer Job at Skechers

WHO WE ARE: Headquartered in Southern California, Skechersthe Comfort Technology Companyhas spent over 30 years helping men, women, and kids everywhere look and feel good. Comfort innovation is at the core of everything we do, driving the development of stylish, ...

Community College of Philadelphia

Internal Auditor Job at Community College of Philadelphia

 ...Posting Details Position Information Position Title: Internal Auditor Requisition Number: SCA00821 General Description The Internal Auditor performs the Colleges internal audit function and assesses risk through the development and execution of the annual...