Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.
As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.
The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.
Main responsibilities:
Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirementsEvaluate complaints for severity and risk, ensuring timely review and processingPrioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sitesParticipate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigationsFocus on operational tasks within the compliant handling processProduce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspectionsCollaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departmentsIdentify and implement continuous improvement opportunities in complaint managementProvide regulatory interpretation and guidance to internal teams and corporate partnersManage and oversee the training within the teamPerform quality checks on activities, prepare reports, and maintain inspection readinessAbout you
Experience:
Related experience in the pharmaceutical industryKnowledge of cGMPs, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting toolsShould be knowledgeable in Quality functions of pharmaceutical industryExperience of working on manufacturing sites is an added advantage
Soft and technical skills:
Proficient in problem-solving, attention to detail, and good organizational skillsAbility to work collaboratively with cross-functional teams in a flexible and proactive mannerStrong analytical skillsAgile thinker and learner, adaptable to complex & dynamic environments
Education:
Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering, Information Technology ore related field
Languages:
Excellent knowledge of English language (spoken and written) Excellent knowledge of German language (spoken and written)
Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment Work from an "Office of the Year 2023" award winner with flexible home office policy Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)
Pursue Progress. Discover Extraordinary.
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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.
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Pursue progress, discover extraordinaryBetter 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!