Signal Management Expert

Main 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)

About you

Experience

Minimum 2 years 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

Soft skills

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

Technical skills

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

Education

Bachelor’s degree in a healthcare, life sciences, or STEM discipline (e.g., Biology, Chemistry, Pharmacy, Public Health, or Biomedical Sciences)

Preferred advanced degree such as Doctor of Pharmacy, Master of Science, PhD

English (Business proficiency)