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Vigilance System Coordinator

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Date: Nov 24, 2022

Location: Brussels, VBR, BE

Company: Terumo BCT, Inc.

JOB TITLE: VIGILANCE COORDINATOR EMEA

 

JOB SUMMARY

Working under minimal supervision, coordinates the EU MDR 2017/45 submission of Vigilance Reports, Trend reports, Periodic Summary Reports, Field Safety Corrective Action Reports, and Post-Market Surveillance Reports and to Notified Bodies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Applies EMEA regulatory requirements for vigilance reporting and assumes responsibility for submitting timely reports and follow up on all products in all EMEA countries.  Plans and arranges own activities, with work being reviewed upon completion.
  • Interacts with regulatory authorities and Notified Bodies. 
  • Identifies and defines vigilance reporting requirements and stays current on changing regulatory vigilance requirements.
  • Manages outside vendors for pharmacovigilance activities, including assessment and reporting requirements.
  • Proactively advises business management of vigilance reporting issues.  Uses a positive, collaborative approach to creating solutions to regulatory/compliance challenges.  Identifies areas where the business can effect improvements and establishes Working Instructions.
  • Acts as liaison with regulatory teams, quality teams (e.g. Field Actions...), commercial teams, and distributors to facilitate vigilance issues
  • Supports Post-Market Surveillance activities

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor’s degree preferably in science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered

 

Experience

Possesses interest in working in a highly regulated environment, preferably with a basic understanding of EMEA medical device and/or pharmaceutical regulations and standards with a focus on vigilance reporting.

 

Skills

  • Demonstrated and effective team skills.
  • Demonstrated ability to identify issues and work with supervisors and management to obtain and implement solutions.
  • Demonstrated ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence.
  • Demonstrated ability to communicate effectively both verbally and in writing in an international environment
  • Demonstrated interpersonal skills and the ability to represent the business in contacts with those both internal and external to the organization.
  • Exhibits commitment to organizational goals and guiding principles.

 

Certificates, Licenses, Registrations

N/A

 

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

 

ADDITIONAL INFORMATION

  • Reporting to: Quality Manager - Post-Market Surveillance


Job Segment: Pharmaceutical, Medical Device, Pharmacovigilance, Business Manager, Science, Healthcare, Management