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