Jobs · New Jersey

Global Safety Officer, I&I

2025 Sanofi Device Innovation Challenge · Morristown, NJ · 1 mo ago
Hybrid$179k–$298k/yrFull-time
We need to output HTML fragment with sections: About the role? The posting includes "About The Job", "About Sanofi", "Main Responsibilities", "Impact" (maybe part of responsibilities), "Signal Detection And Assessment", "Risk Assessment/Risk Management/ Benefit-Risk Assessment", "Submission Activities", "Report Writing", "About You", "Knowledge and Skills", "Formal Education And Experience Required", "Why Choose Us?", "The Salary Range For This Position Is: $178,500.00 - $297,500.00". Also location info: Cambridge, MA / Morristown, NJ. Should we include location as a paragraph? The instruction: do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

or drop it. Location is metadata; we can include a short

maybe after heading? But we should not repeat job title as heading. We can start with a

containing location? Or we can include location in a paragraph after an introductory heading? The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should map sections accordingly. We need to decide which headings to include based on content. We have: - About the role / About The Job: we have a paragraph describing mission etc. Could be "About the role". Use

About the role

then

with that content. - About Sanofi: maybe "About the company" but not in list. Could be part of About the role? Might be separate but not required. Could omit if not needed. But we have content about Sanofi mission; could be included under About the role or separate "About Sanofi". The instruction: Prefer a few substantive sections over many thin ones. So maybe combine About the role and About Sanofi into one section "About the role". But we have separate headings in original: "About The Job" and "About Sanofi". Could combine. - Responsibilities: we have "Main Responsibilities:" then bullet list (actually sentences separated by line breaks). We'll make

Responsibilities

then
  • each item. - Impact: seems part of responsibilities but could be separate. Might be considered part of responsibilities. Could combine. - Signal Detection And Assessment: could be a subsection under Responsibilities? But we could make its own heading if substantive. The instruction: Prefer few substantive sections over many thin ones. So maybe combine Signal Detection, Risk Assessment, Submission Activities, Report Writing under Responsibilities as subpoints? But they are distinct categories. However we could keep them as separate sections if they have substantive content. Let's see: each has multiple sentences. Could be separate sections: "Signal Detection and Assessment", "Risk Assessment and Management", "Submission Activities", "Report Writing". That's many sections. Might be too many. But we could group them under Responsibilities with subheadings? Not allowed; only h3 for section headings. Could we make each a

    ? That would be many sections. The instruction says prefer a few substantive sections over many thin ones. So maybe we should combine all responsibility-related content into one Responsibilities section, using
    • for each bullet (including the subcategories). That would be many li items but okay. - About You / Knowledge and Skills: we have "About You Knowledge and Skills:" then list of skills. Could be "Knowledge and Skills" heading. - Formal Education And Experience Required: could be "Qualifications" heading. - Why Choose Us?: could be "Benefits" heading (since includes rewards package, health benefits, parental leave). Also we have salary range: could be "Pay" heading. - Benefits: we have health and wellbeing benefits, parental leave. So Benefits section. - Pay: salary range. - Schedule: not present, so omit. We must not include sections with filler like "commensurate with experience". The salary range is present, so we can include Pay. We must not include boilerplate like EEO etc. Remove those. We must preserve all substantive information; do not invent or summarize away detail. So we need to keep all details from the posting, but we can rephrase? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. Means we should not omit details, but we can rephrase? Probably we should keep the original wording as much as possible, but we can format into HTML. We'll copy sentences. We need to remove duplicated lines (the posting appears duplicated). We'll deduplicate. Let's extract substantive content: Location: Cambridge, MA / Morristown, NJ About The Job paragraph: "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. Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?" About Sanofi paragraph: "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 list (as sentences): - Internal & External Safety Expert: Provide PV and risk management expertise to internal and external customers - Safety expert for product - Maintain knowledge of product, product environment, and recent literature - Maintain PV expertise, and understanding of international safety regulations and guidelines - Lead cross functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs) - 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 - Provide strategic and proactive safety input into development plans - Support due diligence activities and pharmacovigilance agreements Impact (maybe separate but we can include as responsibilities): - Ongoing assessment of the safety status of the product - 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 - Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partners - Management of product safety alerts - Ensuring the GPE position is well articulated to and understood by its internal and external customers - Establishment of credibility of GSO function and of GPE Signal Detection And Assessment: - Responsible for signal detection and analysis - Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group - Identify and implement proactive safety analysis strategies to further define the safety profile. - Lead aggregate safety data review activities and coordinate safety surveillance activities Risk Assessment/Risk Management/ Benefit-Risk Assessment: - Provide proactive risk assessment - Co-lead benefit-risk assessment with other relevant functions - Develop risk management strategies and plans and monitor effectiveness - Collaborate with Center of Excellence for Risk Management and Safety Epidemiology Submission Activities: - Represent safety position in cross functional submission teams - Ensure generation, consistency, and quality of safety sections in submission documents - Write responses or contributions to health authorities’ questions - Support preparation and conduct of Advisory Committee meetings Report Writing: - Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report - Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products. About You Knowledge and Skills list: - Excellent clinical judgment - Capability to synthesize and critically analyze data from multiple sources - Ability to communicate complex clinical issues and analysis orally and in writing - Able to develop and document sound risk assessment - Demonstrates initiative and capacity to work under pressure - Demonstrates leadership within cross-functional team environment - Excellent teamwork and interpersonal skills are required - Fluent in English (written and spoken). Formal Education And Experience Required: - M.D. Degree or equivalent. - For MD, Board Certified/Board eligible, or equivalent, is preferred - For M.D., minimum 3 years 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. Why Choose Us? paragraph: - 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. Salary range: "The Salary Range For This Position Is: $178,500.00 - $297,500.00" Also note: "All compensation will be determined commensurate with demonstrated experience." That's filler? It's a statement but maybe considered boilerplate? It's not a specific value; it's a generic statement. The instruction: Do NOT emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. For Pay we have a specific range, so we can include Pay section with that range. The statement about compensation being determined commensurate with experience is filler; we can omit it. Also "Employees may be eligible to participate in Company employee benefit programs." That's generic; we can omit as filler. Additional benefits information can be found through the LINK (opens in new window). That's boilerplate; omit. We also have hashtags #GD-SA #vhd etc; omit. Now we need to decide sections. Potential sections: - About the role (combining About The Job and About Sanofi) - Responsibilities (including all responsibility bullets) - Knowledge and Skills - Qualifications (Formal Education And Experience Required) - Benefits (Why Choose Us? includes rewards package, health benefits, parental leave) - Pay (salary range) We could also include a short paragraph for location maybe as a

      before sections. We must not repeat job title as heading. So we start with maybe a

      for location. Let's craft HTML:

      Location: Cambridge, MA / Morristown, NJ

      About the role

      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. Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep

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