Jobs · OTHR · New Jersey

Signal Management Expert

Sanofi · Morristown, NJ · 2 days ago
On-siteOTHRFull-time

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
  • Maintains the process and systems for ongoing activities, continual improvement initiatives, metrics and oversight
  • 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:

  • 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
  • Able 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

Why Choose Us?

  • Bring the miracles of science to life alongside a supportive, future focused team
  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
  • Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs
  • Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science
  • Help improve the lives of millions of people globally by making drug development quicker and more effective

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce.

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