Global Safety Officer

<p><b>Job Title:</b> Global Safety Officer</p><div><p><b>Location:</b> Morristown, NJ Cambridge, MA</p></div><p></p><p></p><p><b>About the Job</b></p><p></p><p>Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&amp;D, you’ll drive breakthroughs that could turn the impossible into possible for millions.</p><p></p><p><b>About Sanofi:</b><br />We’re an R&amp;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.<br /> </p><p></p><p><b><u>Main Responsibilities</u></b></p><p><b> </b></p><p><b>Internal &amp; External Safety Expert with a clear and contemporary understand of Benefit Risk:</b></p><ul><li><p>Provide PV and risk management expertise to internal and external customers</p></li><li><p>Safety expert for product must have an attitude of continuous learning and understand the product attributes and science</p></li><li><p>Maintain knowledge of product, product environment, and recent literature</p></li><li><p>Maintain expertise in drug safety and PV, and understanding of international safety regulations and guidelines</p></li><li><p>Lead cross functional Safety Management Teams (SMTs) and GPV internal Safety Analysis Teams (SATs)</p></li><li><p>Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations</p></li><li><p>Provide strategic and proactive safety input into development plans</p></li><li><p>Support due diligence activities and pharmacovigilance agreements</p></li></ul><p></p><p><b>Impact:</b></p><ul><li><p>Ongoing assessment of the safety status of the product</p></li><li><p>Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling</p></li><li><p>Review, preparation, and/or contribution to questions/requests from health authorities, ethics committees/ IRBs, external partners</p></li><li><p>Management of product safety alerts</p></li><li><p>Ensuring the GPV’s position is well articulated to and understood by its internal and external stakeholders</p></li><li><p>Continued visibility and Establishment of the credibility of GSO role/function and consequently GPV Signal Detection and Assessment:</p></li><li><p>Responsible for overseeing from multiple contributors signal detection and analysis</p></li><li><p>Collaborate with Center of Excellence for Signal Detection and Data Mining and the Safety Epidemiology group</p></li><li><p>Identify and implement proactive safety analysis strategies to further define the safety as well as Benefit Risk profile.</p></li><li><p>Lead the review of aggregate safety data and related activities as well as coordinate safety surveillance activities</p></li></ul><p></p><p><b>About You</b></p><p><b> </b></p><p><b><u>Knowledge and Skills</u></b></p><ul><li><p>Excellent clinical judgment</p></li><li><p>Articulate and clearly understood in telephone communications</p></li><li><p>Capability to synthesize and critically analyze data from multiple sources supported by sound clinical reasoning</p></li><li><p>Ability to communicate complex clinical issues and analysis orally and in writing</p></li><li><p>Able to develop and document sound risk assessment</p></li><li><p>Demonstrates initiative and capacity to work under pressure and with a good sense of Prioritization of business critical deliverables</p></li><li><p>Demonstrates leadership within cross-functional team environment</p></li><li><p>Excellent teamwork and interpersonal skills are required</p></li><li><p>Fluency in English (written and spoken).</p></li></ul><p><b> </b></p><p><b><u>Formal Education And Experience Required</u></b></p><ul><li><p>M.D., D.O. or equivalent</p></li><li><p>Board Certified/Board eligible, or equivalent, is preferred</p></li><li><p>Minimum 3 years&#39; total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered. Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience</p></li></ul><p></p><p><b>Why Choose Us?</b></p><ul><li><p>Bring the miracles of science to life alongside a supportive, future-focused team.</p></li><li><p>Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.</p></li><li><p>Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.</p></li><li><p>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.</p></li></ul><p></p><p>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.</p><p></p><p>#GD-SA <br />#LI-SA    <br />#LI-Onsite</p><p>#vhd </p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1>Pursue <i>progress</i>, discover <i>extraordinary</i></h1><p>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.</p><p></p><p>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.</p><p></p><p>Watch our <a href="https://www.youtube.com/watch?v&#61;SkpDBZ-CJKw&amp;t&#61;67s" target="_blank">ALL IN video</a> and check out our Diversity Equity and Inclusion actions at <a href="https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness" target="_blank">sanofi.com</a>!</p><p></p><p></p><p><i>US and Puerto Rico Residents Only</i></p><p>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.</p><p></p><p><i>North America Applicants Only</i></p><p></p><p>The salary range for this position is:</p>$172,500.00 - $287,500.00<p></p><p>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 <a target="_blank" href="https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid&#61;sanofi">LINK</a>.</p>