**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). **Why choose us?** 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. \#LI-EUR **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)