Vigilance Analyst

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

We are looking for a Vigilance Analyst who will work and evolve within the Pre-Post Market Immunology quality department (management of quality, vigilance, PMS, field actions) and who will report to the Vigilance Operational team Immunoassays Manager within a team of 9 people.

What will your responsibilities be?

• Collect and consolidate data for post-market Quality (Vigilance, FA, PMS) reports or periodic safety update reports (PSUR) within the Pre-Post Market Immunology franchise.
• Regularly collect and consolidate vigilance and PMS key performance indicators (KPIs), follow up on action plans related to these KPIs with quality management representatives (QMR).
• Assist vigilance operational teams in the vigilance process
• Monitor open non-conformities for late reports or incorrect classification of potentially reportable events (PRE) from technical complaints.
• Monitor actions associated with CAPA or audit/inspection findings.
• Support internal preparation for internal/external audits or inspections related to vigilance activities or field actions.
• Assist vigilance and PMS teams with changes/updates to tools (e.g., TrackWise Digital by writing and executing test cases, ISOTOPE).
  
  

Who are you?

• Significant experience of at least 5 years in Data Analysis.
• IT skills: Office Suite, especially Excel, and data analysis software (Isotope), strong sensitivity to new technologies (AI...).
• Experience in the quality field and/or knowledge of regulatory requirements (EU, US) would be appreciated.
• Communication, collaboration spirit, and agility.
• Rigor, attention to detail, and curiosity.
• Proactive, initiative-taking.
• Fluent in English & French.
  
  

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.