Signal Management Expert

Sanofi; Morristown (NJ); On-site; USD 122,000 - 177,000; Full time

Benefits offered by this job

Health benefits

14 weeks parental leave

Job summary

Sanofi in Morristown, NJ is seeking a Signal Management Expert to operationalize signal management within our Global Safety organization, collaborating with GSO and PVS to optimize benefit-risk profiles. You will lead process improvements, oversee signal detection systems, and partner with digital teams to implement new platforms while ensuring compliance with US/EU regulations.

Candidates should have at least 2 years in pharmacovigilance or pharma, a healthcare/Life sciences degree, and strong

Qualifications

• Experience in a pharmaceutical/biotech regulated environment.
• Evaluation, interpretation, and communication of scientific data.
• Experience implementing process improvements (CAPAs).
• Working knowledge of pharmacovigilance and drug safety practices.

Responsibilities

• Collaborate with PSPV stakeholders to ensure a compliant signal management process.
• Manage the process and systems for routine signal detection and tracking of signal assessment.
• Monitor regulations, literature, and professional societies for insights and innovation.
• Partner with Sanofi digital to implement digital systems for signal detection and management.
• Evaluate signal detection data sources, methods, and tools to enhance safety surveillance.
• Provide training and ongoing support to GSOs, PVS, Therapeutic Area Heads, and Country Safety Heads.
• Coordinate and oversee outsourced PV activities.

Skills

Pharmacovigilance

CAPA implementation

Cross-functional collaboration

Regulatory knowledge US/EU

Data processing & MS Office

Education

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

Doctor of Pharmacy / MSc / PhD (preferred)

Tools

MS Office

Job description

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. Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's 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 people's 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 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)

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.

Benefits

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• High-quality healthcare.
• Prevention and wellness programs.
• At least 14 weeks’ gender-neutral parental leave.
• Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Equal Opportunity

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.

The salary range for this position is: $122.250,00 - $176.583,33. All compensation will be determined commensurate with demonstrated experience.

German

Wir sind ein forschendes Biopharma-Unternehmen, das KI anwendet und sich dafür einsetzt, das Leben der Menschen zu verbessern und verantwortungsvoll zu wachsen. Unser Team wird von einem Ziel geleitet: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern. Wir möchten eine gesündere, widerstandsfähigere Welt schaffen und das Unmögliche möglich machen, indem wir Medikamente und Impfstoffe für Millionen von Menschen weltweit entdecken, entwickeln und bereitstellen. Erfahren Sie mehr über uns auf www.sanofi.com oder schauen Sie sich unseren Film an: We are Sanofi Starte eine Karriere, die einen Unterschied macht. Neuerfindung liegt in unserer DNA. Sie hat unsere Entwicklung von einem kleinen französischen Unternehmen zu einem der weltweit führenden Biopharma-Unternehmen vorangetrieben. Ob es darum geht, KI zu nutzen, um die Zeiten der Arzneimittelforschung zu verkürzen, oder Vertrauen im Gesundheitswesen aufzubauen – du kannst unseren Teams dabei helfen, das Leben für Patient*innen, Partner*innen und Gemeinschaften zu verbessern. Hier entwickelst du deine Karriere weiter. Wir öffnen dir die Tür, um neue Möglichkeiten zu entdecken, deine Grenzen zu erweitern und dich mit Menschen zu vernetzen, die von einem gemeinsamen Ziel angetrieben werden: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern.