Global Pharmacovigilance Quality Audit & Inspection Readiness Coordinator - VIE Contract

Sanofi•Morristown, NJ

2d•Onsite

About The Position

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?

Requirements

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.
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).
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…)
Fluent English.

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.

Benefits

Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
Help improve the lives of millions of people globally by making drug development quicker and more effective.
Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe.
At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.
Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow.
We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries.
Sanofi unites people who are passionate about solving healthcare needs across the world.
Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.