Eli Lilly and Company · 7 hours ago
Associate Director - Pharmacovigilance (PV) Systems Strategy and Implementation
US, Indianapolis IN
Full-time
Onsite
Lead/Staff, Director/Executive
$116K/yr - $169K/yr
2+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. The Associate Director PV Systems Strategy and Implementation is responsible for developing and maintaining systems that support the PV organization's objectives, analyzing workflows, and driving technology and analytics strategies.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Proactively assesses and advises PV business on key upcoming/emerging trends (based on assessment of internal data/trends and external environmental changes)
Research new technologies and work with business, corporate analytics, and IT teams in building and deploying applications/analytics models
Influences and drives PV technology strategy through external/internal benchmarking, business process automation needs, and analytic trends
Leads strategic cross-functional projects across PV and PV Partners for automation, technology and analytics needs
Maintain deep technical understanding of safety process knowledge in order apply technology and automation to PV processes
Lead analytics and automation solutions to address large cross-functional issues for PV and associated business partners
Provides experience developing use cases, translates business issues into user stories and subsequent mapping into a technology solution
Responsible for the oversight and/or development of new and existing PV systems, tools, technologies and strategies in support of related business processes (i.e. timeline updates, project status reports, risk management, etc)
Drive business readiness activities for technology implementations
Accountable for maintenance of PV systems as system owner or custodian while strategically influencing and driving the system change management process as needed
Partners with Quality to ensure that standard validation principles and system development methodologies are used to build and maintain PV-based applications
Employs applications and development efforts with PV organization and other regional centers to maintain alignment and foster consistency as appropriate across PV
Provides consultation and partners with PV leadership and Quality to deliver upon regulatory and audit requests
Leads engagement to define, deliver, and report measures to understand the health of our systems
Works across PV to provide oversight to the definition and implementation of tools and applications that provide insight into operations
Deep knowledge of existing regulations/guidelines and trends for PV automation and technology (i.e. e2B, eDC, AI, safety mailings) to proactively motivate change to maintain compliance
Understands the confidential nature of company information and takes vital steps to ensure its protection
Provides subject matter expertise for inspections and audits in relation to safety systems
Ensures that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties
Understand the roles of the EU Qualified Person (QP) and ensures support is provided to fulfill the QP legal responsibilities
Qualification
Required
Bachelor's degree (preferred within health science or information technology)
2+ years of experience supporting drug development areas (e.g., Safety, Clinical, Project Management, Tech@Lilly, etc.)
2+ years of experience with data, reporting, and processes/systems
2+ years implementing small and large systems/technology projects
Demonstrates understanding of the PV safety system and business process
Experience in the pharmaceutical industry and/or PV or clinical research
Preferred
Demonstrates leadership in communicating effectively in written and verbal formats to various management levels
Demonstrates effective collaboration with teams spanning multiple geographies to develop and deliver applications
Strong leadership and project management skills
Represent the organization's analytics capabilities in various internal and external forums and conferences
Experience in operational and workflow analysis
Demonstrates ability to be a self-starter comfortable with creating structure in an ambiguous environment; possesses a shown history of being a quick learner
Demonstrates experience with Artificial Intelligence (e.g. Machine Learning, Natural Language Processing, etc.)
Demonstrates solid understanding and application of Computer System Quality (CSQ) requirements
Experience working in a highly regulated environment
Benefits
Company bonus (depending, in part, on company and individual performance)
Eligibility to participate in a company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-01-12
2026-01-12
Company data provided by crunchbase