RFPAttachment5LaborCategoryDescriptions.pdf

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ATTACHMENT NO. 5: FAERS LABOR CATEGORY DESCRIPTIONS

The labor categories in the list below can be further subdivided by knowledge/skill level. Definitions of these knowledge/skill levels are shown in this chart:

Labor Category Description

Entry-Level – (I) Applies fundamental concepts, processes, practices, and procedures on technical assignments. Performs work that requires practical experience and training. Work is performed under supervision.

Journeyman – (II)

Possesses and applies expertise on multiple complex work assignments.

Assignments may be broad in nature, requiring originality and innovation in determining how to accomplish tasks. Operates with appreciable latitude in developing methodology and presenting solutions to problems. Contributes to deliverables and performance metrics where applicable.

Senior – (III)

Possesses and applies a comprehensive knowledge across key tasks and high impact assignments. Plans and leads major technology assignments. Evaluates performance results and recommends major changes affecting short-term project growth and success. Functions as a technical expert across multiple project assignments. May supervise others.

Program Manager (III)

• Provides direct supervision for technical and non-technical staff and serves as the company’s authorized interface with the Government Contracting Officer (CO), the Contracting Officer's Technical Representative (COTR), government management personnel and customer agency representatives.

• Manages technical and non-technical teams providing oversight management of contract support operations and planning and production of contract deliverables.

• Possesses Program Management Professional (PMP) or equivalent certification.

IT Project Manager (II and III)

• Develop and maintain project plans

• Directs and assigns project tasks and manages overall project releases

• Reviews all technical work products and supports Technical team with guidance and design related support.

• Coordinates work of team with FDA OIM and business; and supports action item traceability, risk management, escalations and FDA communications

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• Demonstrated knowledge and experience working on pharmacovigilance platforms and implementation experience of Commercial Off-The-Shelf (COTS) pharmacovigilance tools is required

• Experience with MS Project, MS PowerPoint, and Visio.

• Possesses Program Management Professional (PMP) or equivalent certification.

• Overall knowledge of Enterprise Performance Life Cycle (EPLC) and agile project/systems development

• Knowledge and experience with Capital Planning and Investment Control (CPIC) and Earned Value Management (EVM) processes.

Software Systems Engineer (II and III)

• Experience in the following software packages: SQL, PL/SQL, Oracle database 11g and above, Oracle JDK, Oracle Single Sign-On, and ERwin Collaboration tools.

• Demonstrated experience with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B (E2B is the international standard for transmitting medicine adverse event reports) R2 and Health Level Seven International (HL7) R3 messages

• Understanding of the publically available FDA Quarterly Data Extract (QDE) policies, processes, and procedures

• Experience providing industry support and troubleshooting post production issues.

• Experience with log analyses, firewall troubleshooting, configuration patch deployments, troubleshooting subsystems (FLARe & Internet Stats), data call support (# of accounts, server specs, RAM and CPU performance), OS patches, and VDDs

• Support MedDRA dictionary upgrades

• Knowledge and familiarity with cloud computing, hosting and publishing application environment and databases on the cloud.

• Experience in configuring, customizing, and implementing the proposed COTS Pharmacovigilance solution. Support workflow setup, configuration and edit check development. Support COTS administration and patch deployments.

• Experience in implementing ICH E2B R3 data standards and converting ICH E2B (R2) message to ICH R2B (R3) keeping in mind the backward and forward compatibility and data migration issues.

Pharmacovigilance Expert

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• Experience in implementing and optimizing intake, case management and reporting of Individual Case Safety Reports (ICSRs) for both premarket and postmarket setting and product complaint reports, as well as, business analysis experience, specifically, soliciting customer requirements, tracking, documenting, and reporting on planning, user acceptance testing, and training. Working with the Systems and Business Analysts, will be one of the key personnel acting as the liaison between contractor and government teams to ensure requirements are uniformly understood and agreed upon.

• Understanding of different ICSRs intake channels like fax, email, paper including electronic submission via gateway and is able to automate data intake and processing.

• Well versed in International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B (E2B is the international standard for transmitting medicine adverse event reports) data standards and Implementation Guide with experience in converting ICH E2B (R2) message to ICH R2B (R3) keeping in mind the backward and forward compatibility and data migration issues.

• Understanding of auto-coding key data points using dictionaries for product, manufacturer and MedDRA.

• Knowledge of Structured Product Labelling (SPL) product identifiers and characteristics and International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP)

• Experience with the implementation of Commercial off-the-shelf (COTS) Pharmacovigilance software tools

• Provide pharmacovigilance knowledge and guidance to contractor staff, ensuring compliance with industry standards.

• Experience in facilitating meetings, eliciting and documenting requirements, and performing user acceptance testing and training

Subject Matter Expert (III)

Plans, supports, advises, and provides expertise in complex and critical efforts which include specific functional, technical, scientific areas (chemistry / biology/food safety/IT) professional, policies, enterprise application architecture, design review, technical mentorship, and industry specific knowledge of the project. Key responsibilities include: Investigating or identifying business, technology, engineering, operational conducting analysis of these issues; and providing advice in support of major programs/projects. This person, with analytic, technical, and functional experience, oversees and guides both problem analysis and technical solution implementation through final testing and knowledge transfer.

Chemoinformatics Expert

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• Experience with chemoinformatics development toolkits such as Indigo, OpenBabel, RDKit, CACTVS

• Experience with Health Level Seven International (HL7) Structured Product Labeling (SPL)

• Knowledge and familiarity of European Medicines Agency (EMA) International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) data standards

• Demonstrated knowledge of chemical substance classification and association of drug products.

Systems Analyst (II and III)

• Experience in System Analysis, especially in system design, testing, training, and implementation. Acts as release manager for all releases by creating version description documents, obtaining approvals and adheres to technical delivery milestones. Working with the Functional Subject Matter Expert and Business Analyst, will act as the liaison between contractor and government teams to ensure requirements/specifications are uniformly understood and agreed upon.

• Experience performing feasibility studies, Levels of Effort (LOEs), and proof of concepts

• Experience leading code reviews and testing, and performing database ad hoc queries and query optimization

• Experience managing requirements/specifications traceability and requirements/specification documentation (preferably using JIRA and SharePoint) in compliance with FDA guidelines.

• Experience creating technical design and specification documentation (e.g. System Requirements Specifications (SRS), Target State Diagrams, System Architecture and System Design and Test Plans).

• Experience in engineering a system utilizing one or more of the following systems engineering frameworks and methodologies: Zachman Framework, Institute of Electrical and Electronics Engineers (IEEE) 1471, and/or Capability Maturity Model Integration (CMMI)

• Experience generating (physical) data models with ERWin

• Experience with JIRA, Visio, and SharePoint

Business Analyst (II and III)

• Experience with business analysis, especially in soliciting customer requirements, tracking, documenting, and reporting on planning, training, and system requirements

• Liaison between contractor and government teams to ensure requirements uniformity of understanding

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• Experience designing and reporting on questionnaires, surveys, operational performance metrics.

• Overall knowledge of Enterprise Performance Life Cycle (EPLC) and agile development

• Experience in creating functional (i.e. IDEF0), process, and workflow models in Visio and/or BPWin

• Experience managing requirements/specifications traceability and requirement/specification documentation (preferably using JIRA and SharePoint).

• Experience in developing and managing quality plans utilizing one or more of the following quality methodologies: Total Quality Management (TQM), Continuous Improvement, and Benchmarking

• Preferably possess Information Technology Infrastructure Library (ITIL) Foundation certification, or equivalent certification, and has experience in the development and execution of service delivery models

• Preferably possess the International Institute of Business Analysis Level 3 – Business Analysis Professional (CBAP) certification, or the American Society of Quality (ASQ) Manager of Quality/Organizational Excellence (CMQ/OE) certification, or equivalent certification.

Database Developer (II and III)

• Experience with Informatica and Oracle DB suite, i.e. demonstrated proficiency in the following software packages: SQL, PL/SQL, Oracle database 11g and above, Oracle JDK, and Oracle Single Sign-On, PuTTY, and ERwin Collaboration tools.

• Experience in application development, performance debugging, ad-hoc reports, data updates/clean-up and code list maintenance.

• Overall knowledge of Enterprise Performance Life Cycle (EPLC) and agile development

• Knowledge and familiarity of European Medicines Agency (EMA) International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) data standards

Database Administrator (II and III)

• Experience with database administration on 10g, 11g, and 12c, to include performance tuning, tracking Oracle Real Application Clusters (RAC), set up and administration of multiple environments, and VDD (for database).

• Experience with ERWin tool.

Application Developer (II and III)

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• Experience with web application development, Java, PL/SQL and JSON

• Overall knowledge of Enterprise Performance Life Cycle (EPLC) and agile development

• Knowledge and familiarity of EMA ISO Identification of Medicinal Products (IDMP) data standards

• Experience in application development, performance debugging, ad-hoc reports, data updates/clean-up and code list maintenance.

• Experience supporting workflow setup, configuration and edit check development; migration and production dictionary setup; and administration and patch deployments.

Internet Stats Application Developer (III)

• Experience with Qlik sense software development and deployment. Develop custom widgets for Qlik interface.

• Support 508 compliance testing prior to software deployments.

• Support migration to cloud platforms if needed.

• Demonstrated knowledge of and expertise with data warehousing.

FLARe Application Developer (III)

• Experience with Aris Global’s agTracker tool. Support workflow setup, configuration and edit check development.

• Support data migration and production dictionary.

• Support administration and patch deployments.

Help Desk Specialist (I, II, III)

• Manage or participate in the management of the IT help desk

• Demonstrated knowledge and expertise with Service Now, Service Manager, and HP Quality Tools

• Demonstrated knowledge and expertise with SQL to generate specific customer reports

• Preferably possess Information Technology Infrastructure Library (ITIL) Foundation certification and has experience in the development and execution of service delivery models for help desks.

Project Control Specialist (I, II, III)

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• Experience in tracking and reporting on project tasks and deliverables related to project releases

• Knowledge of Capital Planning and Investment Control (CPIC) and Earned Value Management (EVM) processes.

• Schedules, coordinates all user related discussions, and supports meeting management, action items and meeting minutes.

• Experience with MS Project, SharePoint, Clarity, and ProSight

• Overall knowledge of Enterprise Performance Life Cycle (EPLC) and agile development

Test Engineer (I, II, and III)

• Evaluates, recommends, and implements automated test tools and strategies.

• Designs, implements, and conducts test and evaluation procedures to ensure system requirements are met.

• Develops, maintains, and upgrades automated test scripts and architectures for application products. Also writes, implements, and reports status for system test cases for testing. Analyzes test cases and provides regular progress reports.

• Serves as subject matter specialist providing testing know-how for the support of user requirements of complex to highly complex software/hardware applications.

• Directs and/or participates in all phases of risk management assessments and software/hardware development with emphasis on analysis of user requirements, test design and test tools selection.

Documentation Specialist (I, II, III)

• Experience in preparing and proofreading correspondence, reports, and maintaining filing system(s) for a business group or department.

• Experienced with automated word processing, spreadsheet, and graphics workstation programs.

Assists in collecting and organizing information required for preparation of system or process documentation.

• Demonstrated experience to carry out written projects to completion with excellent communication and writing and editing skills.

• Experience with SharePoint, MS Word and PowerPoint, and MS Project

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• Overall knowledge of HHS Enterprise Performance Lifecycle (EPLC)

Training Specialist

• Experience coordinating, developing, and delivering training to the user community.

• Demonstrated expertise in generating training plans and conducting the training according to those plans.

• Experience with coordinating training with analysts, help desks and testing teams for implementation and post implementation activities.

• Expertise in enabling government agency personnel to use information technologies and systems more productively. Services include the development, delivery, and/or coordination of training courses and materials that address specific agency needs.

• Possess thorough knowledge of appropriate hardware and software: e.g. - PCs, Microsoft (MS) Windows, MS Office, pharmacovigilance tools, and applications such as JIRA and SharePoint.

• Understanding and familiarity of computer functions and related technical terminology and how they are applied in everyday business situations.

• Possess exceptional interpersonal skills and superior oral and written communication skills.