About the role
from listingAt Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.
This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
About Lilly
At Lilly, everything we do starts with patients. We unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, our global team of over 50,000 employees work with urgency and purpose to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. We bring our best to this work because people depend on it. If you're driven by purpose and determined to make a meaningful difference for patients, we invite you to bring your skill and your commitment to Lilly.
About Technology@Lilly
At Lilly, technology is not a support function. It is how a global medicine company operates, innovates, and delivers. Lilly in Bengaluru builds the capabilities that make this possible, cloud platforms, AI systems, and automation at enterprise scale, all in service of a purpose that makes this technology work genuinely distinctive, from advancing drug discovery to enabling connected clinical trials to keeping a global medicine company running at the standard patients deserve.
About the Business Function:
CTI-MD enable the digital capabilities that power Lilly's clinical development and patient safety ecosystem. We build connected trial platforms, AI-driven solutions, and data products that support study design, trial execution, clinical insights, and pharmacovigilance. Our teams help ensure patient safety through the collection, assessment, monitoring, and reporting of safety data while accelerating the development of life-changing medicines.
By combining clinical expertise with engineering excellence, we improve patient and site experiences, strengthen regulatory compliance, and drive innovation across the development lifecycle.
Role:
The Sr. System Architect, Global Patient Safety operates at the intersection of business context, product management, engineering, data, AI, and enterprise architecture for the GPS portfolio — accountable for technology strategy, architecture direction, and measurable business outcomes across Pharmacovigilance. This role is split 70% hands-on technical execution including coding and 30% strategy, and shapes the future technology landscape.
The role balances delivery needs with long-term vision for scalable, secure, compliant, and maintainable solutions; drives transformation and future-state platforms; mentors technical leaders; and represents GPS as a global partner in enterprise architecture decision-making — bridging business stakeholders, vendors, and technical teams while building a durable architecture capability inside Lilly.
Operates at the senior system architect level, engaging across the enterprise — including Enterprise Architecture — and providing technical leadership across the full solution lifecycle, from design through implementation
Key Responsibilities:
Portfolio Architecture Ownership — own end-to-end technical architecture across the Safety ecosystem (Case Management, Signals, Reporting) and connected Quality, Regulatory, Clinical, and Data systems; set portfolio-level architecture roadmaps and standards, preparing decisions ahead of delivery rather than resolving them reactively. Understands the pharmacovigilance system, its business context, and adjacent platforms shaping upstream/downstream decisions.
AI / Agentic Architecture Enablement — convert emerging AI/agentic use cases into reusable, governed architecture patterns, translating proofs-of-concept into production-ready solutions that scale across the portfolio; partner with AI, engineering, and vendor teams to embed AI/agentic components responsibly within safety architecture and compliance guardrails. Requires deep, broad technology knowledge — cloud-native services, data products, and responsible-AI controls.
Governance, Risk & GxP Compliance — embed audit-readiness and change-control thinking into architecture patterns, ensuring compliance with FDA/EMA and internal IT/quality policies; maintain architecture documentation in support of audit, inspection, and CSV readiness; evaluate technical debt in legacy Safety and Regulatory systems and shift governance upstream to reduce late-stage compliance issues. Leverages adjacent-system knowledge to drive robust business discussions and influence how GPS platforms evolve.
Vendor Independence & Knowledge Retention — serve as the primary technical authority for architecture judgement, reducing reliance on vendors (e.g., Veeva, Qinesca, etc.), with delivery partners executing within Lilly-owned guardrails; act as the primary technical point of contact for vendor teams, leading design and configuration decisions that protect long-term design integrity.
Product & Business Partnership — partner with Patient Safety, Quality, Regulatory, and IT stakeholders to translate business strategy into technology capabilities, articulating trade-offs and risks that inform prioritisation; participate in strategic planning and portfolio reviews as a trusted advisor to business and technology leadership. Challenges the status quo, recommending improvements to team processes, governance, and control patterns that drive innovation
Global Leadership — represent GPS Tech in global architecture forums, building partnerships across global Patient Safety technology teams; drive shared ownership and accountability models between India and global organisations, promoting Lilly's product operating model principles across GPS. Actively promotes ideas and impacts decisions across multiple teams and capabilities — leading, global architecture direction.
Decision-Making Authority — make strategic architecture recommendations and approve major solution and integration designs across the GPS portfolio; influence technology investment decisions and challenge product, engineering, or vendor approaches when architectural or compliance risks exist; recommend platform standardisation opportunities and escalate enterprise architectural or GxP concerns to leadership when necessary. Breaks down complex portfolio problems into decisions delivering broad business impact and measurable risk reduction.
Talent Development & Technical Leadership — mentor engineering leads, building architecture capability through coaching and communities of practice; create a succession path for future GPS architecture leadership, with emphasis on growing technical talent, and contribute to hiring and talent planning; review and approve technical designs and configuration specifications for quality and compliance. Coaches through design reviews and communities of practice to broaden team impact.
Qualifications Required:
Bachelor's degree in Computer Science, Information Systems, Engineering, or related field (Master's preferred).
12+ years in IT/enterprise/portfolio architecture or senior technical leadership, including 4+ years supporting pharmacovigilance or patient safety technology and processes (case intake, triage, signal management, regulatory reporting).
Demonstrated ownership of architecture decisions at a portfolio or platform level across multiple concurrent programmes.
Proven experience designing, deploying, or governing AI/agentic solutions, scaling POCs into production architecture.
Deep hands-on experience with Pharmacovigilance (Safety) and their integration with Quality, Regulatory, Clinical, and Data platforms.
Strong command and hands-on experience with enterprise integration patterns (APIs, middleware, ETL, data mapping), cloud infrastructure (AWS, Azure), and integration middleware & architecture development.
Experience operating in regulated (GxP) environments, including computer system validation (CSV) and inspection-readiness practices.
Strong communication skills, translating complex technical architecture into business and regulatory language for senior stakeholders.
Experience chairing or presenting to architecture review boards / governance forums, and influencing senior leadership on technology investment and risk trade-offs.
Track record of building and scaling architecture capability within a global, distributed delivery model — including establishing communities of practice and mentoring paths for engineering leads.
Working knowledge of Agile-at-scale and product operating model practices (backlog governance, value-stream mapping) applied to a regulated technology portfolio.
Demonstrate success negotiating and governing multi-vendor delivery arrangements at an enterprise or portfolio scale, with clear separation of Lilly-owned vs. vendor-executed responsibilities.
Demonstrate ability to break down complex, portfolio-level problems into initiatives that drive broad business impact.
Recognised subject-matter expert in one or more core GPS technologies, with demonstrated initiative to continuously learn and adopt emerging tools and technologies.
Coaching and continuous-improvement leadership — growing technical capability, challenging the status quo, and driving adoption of improved architecture practices.
Influence across multiple teams, functions, and governance forums, gaining support from business and technology partners.
Preferred:
Veeva Vault platform training/certification.
Experience in global, distributed delivery models and global technical leadership; experience representing in global enterprise architecture or product governance forums.
Strategic and analytical thinking — preparing architecture decisions ahead of delivery rather than reacting to them.
Strong vendor governance, management, and negotiation skills; ownership mindset managing multiple priorities, stakeholders, and concurrent programmes.
Comfort operating in ambiguity, driving clarity around architecture dependencies and portfolio-level timelines.
Excellent communicator — articulates role scope, independence, and portfolio impact
Functional influence mindset — gains support for architecture decisions across GPS, product, engineering, Quality, Security, and vendor stakeholders.
At Lilly, caring is not only what we do for patients. It is how we work. We believe the people who dedicate themselves to making medicines better deserve an environment that makes their lives better too, one where they are supported, respected, and given the space to do their best work. This is not just a policy. It is who we are.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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