Global Pharmacovigilance Audit & Inspection Readiness Coordinator - VIE Contract

Global Pharmacovigilance Audit & Inspection Readiness Coordinator - VIE Contract

• Location: United States of America, Morristown
• Target start date: 01/05/2025

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

Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As Global Pharmacovigilance Audit & Inspection Readiness Coordinator VIE in our Quality Compliance team you will work with global teams to integrate quality standards and initiatives. Routine activities are Pharmacovigilance (PV) audit preparations and follow up, health authority PV inspection support, audit and inspection findings trending and oversight of Corrective and Preventive Action (CAPA) implementations.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

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.
• Completion of audit/inspections PV related Corrective and Preventive Actions (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:

• 1+ year of experience in Pharmacovigilance / Medical Affairs / Regulatory Affairs or Quality Assurance.
• Experience in CAPA (Corrective and Preventive Actions) management.
  

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.
• Understanding of Pharmacovigilance regulatory requirements such as International International Council for International Organizations of Medical Sciences (ICH/CIOMS), European Union (Good PV practices) and Food and Drug Administration (FDA) regulations in the domain of Pharmacovigilance.
• Knowledge of Microsoft office (proficient use of Excel, PowerPoint, Power BI ).
  

Education:

• Bachelor’s or Master‘s in Pharmacy (BS, RPh, Pharm D) or in nursing (BSN, BScN) or biological science discipline (Biology, Health Sciences).
  

Languages:

• Fluent English (written and verbal).