Job Summary 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 Lillys 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
- Bachelors degree in Computer Science, Information Systems, Engineering, or related field (Masters 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.
- Solid 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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