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Vigilance Expert

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Location: Craponne, France
Position Type: Unfixed Term
Job Function: Supply Chain

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.

bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. Its corporate headquarters are located in Marcy l’Étoile, near Lyon, in France.

Joining bioMérieux is choosing to be a part of an innovative company with a long term vision, committed to the service of public health and carried out with a human-centered corporate culture.

Our Company offers numerous opportunities for professional development. You want to  help save lives across the globe? Join the 13,000 employees of bioMérieux!

 

 

 

What will be your responsibilities at bioMérieux ?

 

  • Part of the post-market quality team which is in charge of the management of clinical commercial operations, vigilance and distributor processes and their implementation world wide (around 150 people worldwide based in more than 40 countries) Assign GA/LA to specialists.
  • Complaint assessment taking into account the risk to patient in compliance with the Vigilance requirement ( EU and FDA regulation, MEDDEV guidelines, French Public Health Code). Make a decision of incident reportability to CA. Complete the associated vigilance reports (eMDR, MIRs)
  • Approve the assessments of complaints and reports to Competent Authorities completed by the Vigilance specialists.
  • Assist  vigilance specialists in answering competent authorities questions.
  • Be the vigilance contact (role) back up of the vigilance manager for the ANSM/ expert in regulation.
  • Manage transversal meetings to make a decision on product issues confirmed on the field and define the actions requested in the field if necessary. Complete the associated documentation. Make a decision to notify the Competent Authorities (FDA, ANSM….) and approved the associated reports in case of FSCA
  • Manage FSCA closures  / Questions from CA related to FSCAs with the specialist.
  • Approve PMS reports  & QSMR data (if needed)
  • Assist Manager in crisis /alerts   
  • Particip to regulatory audits / Inspection (preparation and front room contact)
  • Present at QSMR
  • Back-up of manager to approve Field Action Board meetings minutes & FSCA
  • Assist manager with training of new employees.
  • Perform RACM reviews as needed (US only)
  • Contribute to the Vigilance, Field Actions Procedures and reports

 

Who are you?

 

  • Knowledge and skills:
    • Engineer, Pharmacist
    • 10+ years of experience in Quality and/or Viglance departments
    • Good knowledge the FDA806 and 803, EU Vigilance regulation, MEDDEV guidelines
    • Quality standards 13485, 13850/ISO 9001, QRS 820
    • Softwares skills: office, data analysis software would be appreciated
  • Talents and qualities : 
    • Rigorous and attentive to details
    • Fluent English and French
    • Team spirit
    • Adaptability
    • International adaptability
    • Interpersonal and listening skills
    • Understanding of business needs

 

 

 

Working at bioMérieux means being involved long term with a pioneering, visionary and constantly growing company that allows its employees to live a stimulating and inspiring experience in a fulfilling work environment

Our internal mobility policy offers numerous opportunities for each of our 13 000 employees to blossom throughout their career, while respecting each employee’s individual talents as well as their personal and professional development.

At bioMérieux, over 200 professions - both scientific and non-scientific - offer our employees the opportunity to broaden their fields of expertise and develop cross-functional careers. We provide a rewarding experience in an international company that brings together talents from diverse backgrounds, thus fostering a daily aspiration to go beyond the limits.

Helping improve public health around in the world : our mission gives purpose to every profession practiced within the company.

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

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