Signal Management Operations Lead

Job title: Signal Management Operations Lead

Location: Morristown, NJ / Cambridge, MA

About The Job

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.

Our Team

The Pharmacovigilance and Patient Safety (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize 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 Officer (GSO) and Pharmacovigilance Scientists (PVS) monitoring of product safety throughout the product lifecycle.

The Signal Management Operations Lead (SMOL) will oversee and maintain day-to-day functioning of the signal management process and systems. This will include system ownership of signal detection and management systems, maintaining compliance with regulations, and preparing for audits, inspections and routine metrics oversight. The SMOL will manage Signal Management Experts and maintain oversight of outsourced vendor tasks.

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

• Maintain oversight of the signal management process including business system ownership of signal detection and management systems.
• Evaluate and adapt Sanofi process in compliance with evolving global regulations.
• Define and execute quality document strategy in alignment with global regulatory requirements and Sanofi standards.
• Represent signal management on PSPV and cross functional working groups and continual improvement initiatives
• Perform quality control and quality assurance of signal detection and management activities executed by Sanofi employees and vendor staff
• CAPA development and execution for quality events
• Oversee vendor operations and track KPIs
• Serve as subject matter expert on Signal management for stakeholders internal and external to PSPV.
• Train staff on signal management processes and systems.
• Be representative for audits and inspections (business partner & internal process / system audits)
• Define strategy for signal management acquisition and divestment data exchange
  
  
  

About You

Required Qualifications:

• Work Experience: Minimum of 6 years of pharmacovigilance experience; additional experience is an asset
• Required Skills:Proven ability to lead and manage projects effectively
• Strong facilitation and stakeholder influence capabilities, both within and outside of PSPV
• Excellent written and verbal communication skills
• Familiarity with signal detection and management systems
• Working knowledge of pharmacovigilance regulations (US, EU, and global)
• Education: Minimum of a Master's degree in a STEM discipline or Public Health; PharmD or other advanced life science degree is an asset
• Language Requirements: Fluent in English (written and spoken)
  
  
  

Preferred Qualifications

In addition to the required qualifications, this section should also list the preferred qualifications, knowledge, skills, education, or experience that incumbents may have.

• People management
• Audit and inspection presentation, execution and strategy
• Influencing without authority
• Sanofi standard systems (Jira, Confluence, ServiceNow)
  
  
  

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.
  
  
  

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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.