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Vigilance Reporting Specialist

Category:Contract
Location: Maplewood, Minnesota 55144
Posted:Thu, October 10, 2019
Salary:Up to US$0.0 per hour
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Job Description Summary
The person hired for the position of Vigilance Reporting Specialist will assume responsibility for the complete assessment of medical related incidents of Medical Device/Drug combination products. Assure appropriate prioritization and timely regulatory reporting for medical complaints. Assure compliance with all FDA regulations and internal procedures related to medical complaint reporting.

Primary Responsibilities include but are not limited to the following:
Creates questionnaires to assist and guide partners (internal and external) in collecting information related to medical device/drug combination product complaints.
Evaluates customer feedback and data to determine if sufficient information is available to understand the nature of the complaint.
Contacts health care professionals, end user customers, external partners, and/or internal 3M contacts to gather more data on complaints.
Leveraging nursing knowledge (e.g. regarding medical procedures, anatomy, physiology, surgical procedures, and products) to determine FDA reporting applicability and to escalate alleged injury product complaints to Medical Affairs
Creates clear and complete documentation of the entire investigation and communicate as appropriate.
Makes US FDA regulatory reportability decision on complaints.
Initiates US FDA Medwatch form and complete electronic transmission of data to the US FDA
Monitors and tracks complaint data related to assigned products.
Reconciles 3rd party partner data with internal data to ensure all complaints have been reported appropriately.
Works with cross-functional groups (Regulatory Affairs, Quality Engineers, Medical Complaint Investigators) as required.

Key Performance Indicators:
Complaint record compliance completeness and timely closure
Complaint closure performance
On-time reporting performance
Additional Job Description
Additional Job Description
Basic Qualifications:
Bachelors degree in Nursing (completed and verified prior to start) from an accredited institution
Minimum five (5) years of clinical and/or product experience in a private, public, government or military environment in one or more of the following areas: Perioperative, Emergency Medicine, Critical Care, Medical Device, and/or Pharmaceutical
Current/unrestricted Nursing license in any state

Preferred Qualifications:
Bachelors degree or higher (completed and verified prior to start) from an accredited institution
Experience with FDA regulations and MedWatch submissions
Experience with analyzing, determining root cause and/or assisting with resolution of complex issues
Self-directed and comfortable with a transactional goal structured position
Experience working on a cross functional team
Highly attentive to detail
Excellent communications skills (oral, written and presentation)
Microsoft Office proficient
Basic Qualifications:
Bachelors degree in Nursing (completed and verified prior to start) from an accredited institution
Minimum five (5) years of clinical and/or product experience in a private, public, government or military environment in one or more of the following areas: Perioperative, Emergency Medicine, Critical Care, Medical Device, and/or Pharmaceutical
Current/unrestricted Nursing license in any state

Preferred Qualifications:
Bachelors degree or higher (completed and verified prior to start) from an accredited institution
Experience with FDA regulations and MedWatch submissions
Experience with analyzing, determining root cause and/or assisting with resolution of complex issues
Self-directed and comfortable with a transactional goal structured position
Experience working on a cross functional team
Highly attentive to detail
Excellent communications skills (oral, written and presentation)
Microsoft Office proficient

Experis is an Equal Opportunity Employer (EOE/AA)

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