Lifecycle Safety (LCS) Pharmacovigilance (PV) Systems Subject Matter Expert (SME) (Home-Based)

Job Overview
The role of the LCS PV Systems Subject Matter Expert (SME) is critical to the day to day as well as strategic management of Pharmacovigilance Systems for the IQVIA LCS business (i.e., Safety Aggregate Reporting & Analytics [SARA] Center & Literature Center). The Pharmacovigilance (PV) Systems SME serves as a vital bridge between the needs of the LCS business and the delivery systems that comprise the PV technology stack for the SARA Center / Literature Center. A key responsibility of the PV Systems SME will be to maintain oversight over all aspects of DistillerSR (DSR) Literature Review platform configuration, validation/audit readiness, and access/revocation requests; APEX Literature Tracker, Spotfire literature metrics, PSA transition, vendor liaison, automation, and support any additonal SARA PV systems. The PV Systems SME will be expected to have PV experience, knowledge, and will be intimately familiar with the Pharmacovigilance domain in order to guide and lead the LCS business in leveraging platform cabailities including literature, aggregate and periodic reporting & signal detection services. The PV Systems SME should be able to effectively understand business, regulatory (i.e., 21 CFR Part 11 Compliance) and functional requirements and translate those requirements into system capabilities. As a technical expert the SME will be expected to communicate and represent their domain of expertise to our customers as well as lead and mentor internal technical and operational teams. Similarly, the PV Systems SME will be a key contributor to the LCS RFP and / or bid defense process in order to facilitate growth for the LCS business. The SME will also be expected to liaise and interface with both internal and external technical delivery teams in order to meet customer as well as roadmap deliverables. The SME will be a critical participant in maintaining system compliance and audit readiness as well as defending all aspects of the PV system platforms in audits and inspections.

Essential Functions
• Enforces organizational policies and establishes goals for project teams which develop business applications and information services products.
• Leads small to medium sized cross-functional teams in the execution of full product development life cycle development.
• Under general direction, responsible for all aspects of the development and implementation of assigned projects and provides a single point of contact for those projects.
• Takes projects from original concept through final implementation.
• Interfaces with all areas affected by the project including clients, computer services, and client services.
• Defines project scope and objectives.
• Initiates, plans, executes, controls and closes software and product development activity.
• Participates in setting and enforces project direction with cross-functional teams.
• Plans and manages resource allocations and task assignments within a matrix managed environment.
• Works with management across the organization to define, plan, develop and implement new information products and services.
• Manages, and controls scope, schedule and budget for projects.
• Communicates project status and risks, with associated recommendations, to all stakeholders.
• Ensures adherence to quality standards and reviews project deliverables.
• Provides business guidance to project team.
• May be member of multiple small IT projects.

Qualifications
• Bachelor's Degree Required
• Five (5) years of experience in software and/or product development required
• Project management education and experience.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.