Signal Management Expert

BioSpace; Morristown (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Sanofi US Services in Morristown, NJ is seeking a Signal Management Expert to operationalize the signal management process within a global safety framework. You will support ongoing activities, drive improvements, and oversee assessments while aligning with regulatory requirements and stakeholder needs.

You’ll partner with digital teams to implement new systems and contribute to safety surveillance beyond routine signal detection.

Qualifications

• Minimum 2 years of experience in pharma or regulated environments.
• Experience evaluating scientific data and implementing CAPAs.
• Working knowledge of US and EU pharmacovigilance regulatory requirements.

Responsibilities

• Collaborate across PSPV to ensure compliant signal management processes.
• Manage process and systems for signal detection and tracking.
• Monitor external regulations and literature for insights.
• Partner with Sanofi digital to implement digital signal management systems.
• Coordinate outsourced PV activities and system maintenance.

Skills

Pharmacovigilance

Regulatory knowledge

Cross-functional collaboration

Analytical thinking

Communication

Teamwork

Education

Bachelor's degree in healthcare, life sciences, or STEM

Doctor of Pharmacy / MSc / PhD preferred

Tools

MS Excel

Data processing software

Database systems

Job description

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.

Job Title: Signal Management Expert

Location: Morristown, NJ

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 Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples lives.

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 Sanofis 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)

Experience

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
• 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)

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 its 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. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.