Signal Management Specialist – AI-Driven PV & Safety

Sanofi

Morristown (NJ)

On-site

USD 122,000 - 177,000

Full time

14 days+
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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

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

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