Barcelona, ESP
6 days ago
Signal Methods & Analytics Expert
**Our Team:** The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers. The Signal Management team is an international group of process, method and technology experts dedicated to supporting Global Safety Officer (GSO) and Pharmacovigilance Scientists (PVS) monitoring of product safety throughout the product lifecycle. The Signal Methods & Analytics Expert (SMAE) is responsible for implementation and operational excellence of signal detection and management processes. The SMAE will serve as a PSPV representative and signal detection data, methods and analytics expert on working groups ensuring ongoing compliance with regulations with consideration for stakeholder needs and continual improvement of Sanofi processes and systems. **Main responsibilities:** + Lead innovation and transformation projects to improve the effectiveness and efficiency of signal detection and management across the product lifecycle. + Conduct systematic methodology evaluations of statistical, algorithmic and AI-based signal detection methods for ICSR and other safety data sources + Code proof of concepts and data visualizations for business case to implement new ways of working + Leverage publications from industry and regulators to identify opportunities to improve safety data analytics and inform proof of concept studies. + Support GSOs, PVS and LSOs by identifying the appropriate data source(s) and method(s) to evaluate safety topics from regulators and internally identified signals + Collaborate with other Sanofi functions to leverage available expertise and data in support of enhanced signal detection and evaluation methods. + Partner with Sanofi Digital and /or vendors to scale, validate and implement new methods and/or systems + Provides training for implementation of new systems or processes and ongoing support to roles executing signal detection and signal management processes such as GSOs, PVS, Therapeutic Area Heads, Country Safety Heads + Identify and prioritize opportunities to improve PSPV Signal management processes and deliverables in alignment with strategy, effectiveness, and efficiency. **Experience** : Experience in large, multinational pharma/biotech **Soft skills** : Ability to lead and manage projects; ability to facilitate and influence stakeholders within and outside of PSPV; strong written and verbal communication **Technical skills** : + Knowledge of sources, methods and algorithms for signal detection; familiarity with signal detection and management systems; working knowledge of Pharmacovigilance regulations (US, EU and globally) + Statistical methods for signal detection, machine learning/AI **Education** : + Post graduate degree in STEM or quantitative discipline (MS, MSC or degree in public health) **Languages** : English (Business Fluency) **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) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) 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)
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