EMEA Partners Vigilance Manager

il y a 3 semaines


Villepinte, Île-de-France Guerbet Temps plein
Job Summary

We are seeking a highly skilled EMEA Partners Vigilance Manager to join our team at Guerbet. As a key member of our global organization, you will be responsible for implementing local vigilance and quality systems in the region, drafting procedures and instructions, and providing indicators of conformity and compliance to regulations and processes.

Key Responsibilities
  • Implement local vigilance and quality systems in the region, ensuring compliance with global QMS and local/regional regulations.
  • Draft procedures, instructions, and forms based on the global QMS and local/regional regulations.
  • Provide indicators of conformity and compliance to regulations and processes.
  • Prepare local PV teams for audits and inspections, developing tools, documentation, and digests of main PV inspection findings.
  • Implement CAPA plans following audits and inspections.
  • Coordinate communication between vigilance team at headquarters and local PV teams.
  • Set up regular meetings with partners to review main vigilance topics, explain global processes, and support queries.
  • Perform regulatory intelligence in the region, summarizing and sharing it with teams.
  • Ensure execution of vigilance agreements.
Requirements
  • Scientific background.
  • 4-6 years of experience in corporate vigilance department of a pharmaceutical company.
  • Previous experience in interaction with company business partners required.
  • Written and spoken English mandatory.
Why Join Guerbet?

At Guerbet, we value diversity of talents and offer a global leader with recognized expertise in diagnostic and interventional imaging. We are committed to improving quality of life for patients worldwide. Join our team and be part of a multicultural team of 2,600 people across more than 20 countries.

We #Innovate #Cooperate #Care #Achieve at Guerbet. Guerbet is an Equal Opportunity Employer, committed to diversity and inclusion. We believe that no individual should be discriminated against because of their differences.



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