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16-223-SOL-00079
CFSAN COTS Pharmacovigilance Software, Maintenance, Configurations, and Support
CFSAN’s Adverse Even Management System (CAEMs)
Attachment No. 7: Recommended Labor Categories and Descriptions
| LABOR CATEGORY |
| LABOR CATEGORY DESCRIPTION |
| IT Project Manager |
| 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 end users, computer services, and client services. Develops detailed workplans, schedules, project estimates, resource plans, and staus reports. Conducts project meetings and is responsible for project tracking and anlysis. Ensures adherence to qualtify standards and reviews project deliverables. Provides technical and analytical guidance to project team. Recommends and takes action to direct the anlysis and solutions of problems. |
| Business Analyst |
| Displays strong technical skills coupled with business intelligence and people skills to develop a deep understanding of customer needs, then transforms those needs into application and operational requirements. They are highly skilled at evaluating information gathered through workshops and sureveys, reviewing business requirements docuementation, working with business process descriptions and task analysis, understanding technical designs as well as the specifications, and accurately documenting the required information and data. They communicate with internal teams and external clients to deliver functional requirements like GUI, screen and interface designs, and business workflows. |
| Software Developer II |
| Must have experience configuring, modifying, implementing proposed COTS pharmacovigilance tool. Must have experience interfacing propopsed tool with a variety of other applications and systems. General background in systems analysis, programming, design, data conversion, data migration, and interface management. |
| Test Engineer |
| Evaluate, recommend and implement test tools and strategies in various technical environments. Experience in performance testing, system testing, 508 testing, end user testing, and regression testing. Writes, modifies, and executes test scripts. Reports test results. |
| Training Specialist |
| Organizes and conducts moderately complex training on selected COTS pharmacovigilance tool for both technical and non-technical personnel. May develop instructional curriculum and materials, gathers and assimilates information on subject matter, organizes and condenses material, and prepares course outline, handouts, and visual aid materials. Coordinates with SMEs and business stakeholders to ensure material is in alignment with COTS pharmacovigilance tool's capabilities and stated end user goals and objectives. Maintains records of training activities and program effectiveness. May be required to prepare automated computer based training. |
| Database Specialist II |
| Must have experience configuring, modifying, and implementing proposed COTS pharmacovigilance tool. Evaluates data and system integration data requirements, recommends solutions, and implements changes to COTS pharmacovigilance tool to meet requirements. Determines file organization, indexing methods, and security procedures for specific user application. Commensurate experience and education. |
| Data Standardization Specialist |
| Provide technical support in the evaluation of prime object names, data elements, and other objects. Evaluate proposed objects and their attributes. Ensure that proposed object definitions are clear, concise, technically correct, and that they represent singular concepts. Ensure that the values of object attributes and domains are accurate and correct. Ensure that the proposed objects are consistent with data and process models. Harmonizes data from multiple sources into unified format based on business requirements. Supports data migration activities from legacy to new systems. |
