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)
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