A Quality Inspector inspects and evaluates products according to company quality control standards. Inspects goods or packaging in a production or manufacturing facility.
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Global Pharmacovigilance Quality Audit & Inspection Readiness Coordinator•VIE Contract page is loaded
Global Pharmacovigilance Quality Audit & Inspection Readiness Coordinator•VIE Contract
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locations
Morristown, NJ
time type
Full time
posted on
Posted 3 Days Ago
time left to apply
End Date:
December 11, 2026 (30+ days left to apply)
job requisition id
R2867265
Global Pharmacovigilance Quality Audit & Inspection Readiness Coordinator•
VIE Contract Location:
United States of America, Morristown
Target start date: 01/12/2026 iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
PLEASE NOTE
that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
PLEASE NOTE
that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address. About the job Global Pharmacovigilance (PV) Quality works with global teams to integrate quality standards and initiatives. Routine activities are PV audit preparations and follow up, health authority PV inspection support, audit and inspection findings trending and oversight of CAPA implementations. Join the engine of Sanofi's mission — where deep immunoscience meets bold, AI-powered research. In R D, you'll drive breakthroughs that could turn the impossible into possible for millions. Ready to get started? About Sanofi We're an R D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system•and innovative pipeline•enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main responsibilities:
Marketing Authorization Holders/Sponsors audit and/or inspection readiness comply with the business partner agreement and/or regulatory obligations, specific to pharmacovigilance.
Active involvement in the organization of appropriate support for the preparation, conduct and follow-up of Global Quality audits, Business Partner, or Service Provider audits impacting global PV processes, until closure, e.g. support the management of pre-requests, participation in the back room, follow up of CAPAs (Corrective and Preventive Actions).
Completion of audit/inspections PV related CAPAs to ensure timely completion and effectiveness to prevent recurrence.
Participation in the ongoing permanent inspection preparedness and readiness of PSPV and country PV offices in anticipation of Regulatory inspections and audits. Active involvement in the preparation, conduct and follow-up of regulatory inspections impacting PV until closure.
Support external relations with Inspectorates / Agencies / Pharma associations to ensure surveillance of PV regulations in the field of PV inspections and benchmark on recurrent PV findings. About you
Experience:
Experience in Pharmacovigilance / Medical Affairs / Regulatory Affairs or Quality Assurance.
Experience in CAPA (Corrective and Preventive Actions) management.
Understanding of Pharmacovigilance regulatory requirements such as International (ICH/CIOMS), EU (Good PV practices) and FDA regulations in the domain of Pharmacovigilance.
Soft and technical skills:
Capability to work under extreme pressure.
Excellent communication skills (oral and written).
Excellent organizational and planning capabilities.
Ability to work in transversal/cross functional teams.
Excellent teamwork and interpersonal skills.
Ability to take initiative and to overcome challenges.
Ability to interact with inspectorates from Health Authorities in a constructive manner.
Knowledge of MS office (proficient use of Excel, PowerPoint, Power BI).
Education:
Bachelor's or higher in Pharmacy (BS, RPh, Pharm D) or Bachelor's or higher in nursing (BSN, BScN) or biological science discipline (Biology, Health Sciences…).