Job Title: Signal Management Expert
Location: Morristown, NJ
About the job:
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.
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 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)
The salary range for this position is:
$122.250,00 - $176.583,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
