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Eli Lilly is seeking a Senior System Architect for its Global Patient Safety (GPS) portfolio within the Clinical Trial Innovation and Medical Development (CTI-MD) function in Bengaluru. This is a high-impact technical leadership role operating at the intersection of business strategy, product management, engineering, data, and AI—accountable for technology strategy, architecture direction, and measurable business outcomes across the pharmacovigilance ecosystem.
The role is split approximately 70% hands-on technical execution (including coding) and 30% strategy. You will own end-to-end technical architecture across the Safety ecosystem (Case Management, Signals, Reporting) and connected Quality, Regulatory, Clinical, and Data systems. Key responsibilities include:
**Portfolio Architecture Ownership:** Set portfolio-level architecture roadmaps and standards across the Safety ecosystem; prepare decisions ahead of delivery rather than resolving them reactively. Understand pharmacovigilance systems, business context, and adjacent platforms to shape upstream and downstream decisions.
**AI/Agentic Architecture Enablement:** Convert emerging AI and agentic use cases into reusable, governed architecture patterns. Translate 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.
**Governance, Risk & GxP Compliance:** Embed audit-readiness and change-control thinking into architecture patterns. Ensure 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.
**Vendor Independence & Knowledge Retention:** Serve as the primary technical authority for architecture judgement, reducing reliance on vendors (e.g., Veeva, Qinesca). 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. Articulate trade-offs and risks that inform prioritization. Participate in strategic planning and portfolio reviews as a trusted advisor.
**Global Leadership:** Represent GPS Tech in global architecture forums. Build partnerships across global Patient Safety technology teams. Drive shared ownership and accountability models between India and global organizations.
**Decision-Making Authority:** Make strategic architecture recommendations and approve major solution and integration designs. Influence technology investment decisions. Challenge product, engineering, or vendor approaches when architectural or compliance risks exist.
**Talent Development & Technical Leadership:** Mentor engineering leads and build architecture capability through coaching and communities of practice. Create a succession path for future GPS architecture leadership. Review and approve technical designs and configuration specifications.
Lilly's CTI-MD function enables digital capabilities that power clinical development and patient safety ecosystems. The organization builds connected trial platforms, AI-driven solutions, and data products supporting study design, trial execution, clinical insights, and pharmacovigilance. By combining clinical expertise with engineering excellence, the team improves patient and site experiences, strengthens regulatory compliance, and drives innovation across the development lifecycle.
**Requirements:**
- 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
- 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 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 experience (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
- Track record of building and scaling architecture capability within a global, distributed delivery model
- Working knowledge of Agile-at-scale and product operating model practices applied to regulated technology portfolios
- Demonstrated success negotiating and governing multi-vendor delivery arrangements at enterprise or portfolio scale
- Ability to break down complex, portfolio-level problems into initiatives driving broad business impact
- Recognized subject-matter expert in one or more core GPS technologies
- Coaching and continuous-improvement leadership mindset
- Influence across multiple teams, functions, and governance forums
**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
- Strong vendor governance, management, and negotiation skills
- Comfort operating in ambiguity
- Functional influence mindset across GPS, product, engineering, Quality, Security, and vendor stakeholders
