Associate MDR/Vigilance Specialist Job at Planet Pharma, Minnesota

a3lWQk5FbXk0c01SbmNQUlVabkJaNnhaR2c9PQ==
  • 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

Simply Good

Creative Services Director Job at Simply Good

 ...Simply Good is seeking a Director of Creative Services to lead high-impact, consumer-centric creative across a portfolio of nutrition-...  ...ensures all creative work, produced internally or through external agencies, is strategically aligned, on brand, and designed to engage and... 

Wayne J. Griffin Electric, Inc.

Administrative Assistant Job at Wayne J. Griffin Electric, Inc.

 ...to be part of our team, and our commitment to supporting each employees growth and wellbeing. We are looking for a full-time Administrative Assistant who will work as part of a dynamic team that provides critical support to our Project Management efforts. This role has... 

HumanEdge Health

Licensed Master Social Worker Job at HumanEdge Health

 ...in accordance with facility standards Requirements: Active LMSW license and Master's degree in Social Work Minimum 2 years of social work experience (ER or hospital experience preferred) Strong crisis assessment and de-escalation skills Excellent communication... 

Insight Global

Inventory Specialist Job at Insight Global

 ...Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to... 

BlackRock Resources LLC

Senior Scheduler "Data Center" Job at BlackRock Resources LLC

 ...Qualifications To qualify for the role, you must have A bachelor's degree in engineering, Project Management, Business Administration, or other technical discipline and approximately fifteen (15) + of related work experience Experience scheduling $50M+ projects...