Job title: Signal Management Operations Lead
Location: Morristown, NJ / Cambridge, MA
About the job
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.
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
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:
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 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.
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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Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.
North America Applicants Only
The salary range for this position is:
$178,500.00 - $257,833.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
