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Senior Business Systems Analyst (R1060617) in Morrisville, NC at IQVIA™

Date Posted: 4/1/2019

Job Snapshot

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Job Responsibilities

• Defines project requirements for end to end pharmacovigilance (PV) activities by identifying key deliverables, phases and acceptance criteria, to guide stakeholders and developers/engineers to help drive the development of new applications and features
• Performs detailed data requirements gathering and analysis to provide high quality and detailed requirements, ensuring the closest involvement and agreement from the user community. Responsible for overall quality of data requirements matching to business solution expectations/ needs.
• Formulates and defines business scope and objectives of PV through research and fact-finding combined with an understanding of business system and drug safety industry requirements.
• Consults with multiple stakeholders (e.g. the sponsor / medical monitor / drug safety physician) to construct the system requirements
• Looks at every problem and our solutions in the eyes of our business partners. Works with stakeholders in all business units to formulate scope and objectives for new initiatives. Partners with business stakeholders and business engagement managers to prioritize, analyze, define and manage backlog by gathering enhancement requests and helping with project requests as the business needs evolve.
• Understand current pharma/biotech industry techniques/ conventions, client Standard Operating Procedures (SOPs), WPs and project requirements according to regulatory, ICH and GCP guidelines for elicitation, analysis, and specification Communicate technical concepts to non-technical audiences, and PV business concepts to technical audiences.
• Be a “go to” Subject Matter Expert (SME) for end to end PV related activities for IQVIA’s trial and clinical data.
• Develop training and support programs to explain the detailed process of case processing parameters like narrative writing, labeling, causality assessment, seriousness criteria, coding of drugs and adverse events through Med DRA and company dictionaries for reports origination from different sources like clinical trial, spontaneous, compassionate, patient registries, health authority, license partners as well as litigation cases as needed.
• Develop the requirements for relevant safety sections to the core data sheet, protocols, investigator’s brochures, clinical study reports, product labeling/package insert, investigator communications and other clinical documents.
• Develops project functional requirements documentation in the form of user stories, process flows, and user acceptance criteria. Supports QA and UAT teams. Prototypes/produces system documentation data models, data flows, and process flows.
• Explain customer’s PV requirements correctly to the internal implementation team. Prepare and explain demo environment of system as necessary for customer workshop.
• Provide an oversight on operational activities to the internal team, and have a strong understanding of study protocol, therapeutic indication, budget, and scope of work for assigned projects.
• Deliver precise drug safety functional specifications to include functional hierarchy, workflow, business rules, interface design and definitions, outstanding issues, data analysis, and data mapping to customers and development staff
• Analyzes the current business environment to detect critical deficiencies and identify improvement opportunities. Responds to software development platform questions and troubleshoots efforts by having a thorough understanding of the business processes and flows, thereby enabling the analysis of business requirements and the development of solutions for the business functions.
• Conduct gap analysis between application and stated customer requirements and collaborate with architects and developers to estimate project impact.
• Update and maintain a Requirements Traceability Matrix.
• Create, update and follow-up Jira tickets with details, owner and due dates.

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

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1060617