Signal Management Expert

Sanofi•Cambridge, MA

1d•$122,250 - $176,583•Onsite

About The Position

As Signal Management Expert within our R&D team, you will be part of a cutting-edge safety group dedicated to optimizing 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 Officers (GSO) and Pharmacovigilance Scientists (PVS) in monitoring product safety throughout the product lifecycle. As Signal Management Expert (SME), you will be responsible for operationalizing the signal management process, including support of ongoing activities, continual improvement initiatives, metrics and oversight, and partnering with digital teams on the implementation of new systems with careful consideration to global regulations and stakeholder needs. 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. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

Minimum 2 years of experience in a pharmaceutical, biotech, or other regulated environment
Evaluation, interpretation, and communication of scientific data
Experience identifying, evaluating, and implementing process improvement initiatives including corrective and preventative actions (CAPAs)
Working knowledge of pharmacovigilance and drug safety practices including US and EU regulatory requirements
Working knowledge of common data processing software and database systems
Ability to map, analyze and measure processes
Strategic thinker with ability to understand and assess impact of interconnected activities, projects, and systems
Proficiency with MS applications
Bachelor's degree in a healthcare, life sciences, or STEM discipline (e.g., Biology, Chemistry, Pharmacy, Public Health, or Biomedical Sciences)
English (Business proficiency)

Nice To Haves

Team player that communicates and performs effectively in a cross-functional, collaborative environment
Self-motivated, able to prioritize on impact and a Sanofi first perspective
Ability to influence across stakeholder groups and levels of the organization
Preferred advanced degree such as Doctor of Pharmacy, Master of Science, PhD

Responsibilities

Collaborates with stakeholders across PSPV to ensure a compliant and efficient signal management process accounting for interdependencies with other PV and cross functional activities
Manages the process and systems for routine signal detection and tracking of signal assessment
Monitors external environment (i.e., regulations, literature, professional societies) for insights and innovation of the Sanofi signal management system
Partners with Sanofi digital to administer, improve and implement digital systems used to perform signal detection and management
Understands and evaluates signal detection data sources, methods, and tools to enhance Sanofi’s safety surveillance processes and systems
Provides training and ongoing support to roles executing signal detection and signal management processes such as GSOs, PVS, Therapeutic Area Heads, Country Safety Heads
Coordinates and oversees outsourced PV activities (i.e., maintenance of signal detection schedules, business administration of systems)