Attachment 1 Pricing Worksheet.xlsx

GOV Labor Catagories

Minimum/General Experience: A a minimum of five (5) to eight (8) years demonstrated experience managing multiple smaller projects or one or two moderate-size projects, with strong oral, presentation, and written communication skills.

Duties/Functional Responsibilities: Manages multiple smaller projects or one or two moderate-size projects, with full responsibility for interpreting, organizing, executing, and coordinating projects and major tasks on larger projects.

Plans, develops, and executes engineering or scientific projects, schedules project staff, assigns work, tracks progress, and reports to the client and management.

Plans, develops, and executes engineering or scientific projects or tasks within projects, addressing unique or complex problems or specialty areas, which may involve research of the subject area, definition of scope, selection of investigative approaches, development of concepts/solutions, and carrying out the task/project independently or as a team member.

Demonstrates knowledge and experience working on pharmacovigilance platforms and implementation experience of Commercial Off-The-Shelf (COTS) pharmacovigilance tools.

Acts independently on technical matters pertaining to his/her field, and serves in a lead technical role on projects and proposals/interviews.

Plans/develops budgets and prepares proposals, and reviews project deliverables with emphasis on engineering/scientific and technical quality, client satisfaction, and project profitability.

Data Scientist II Minimum Education: Bachelor's or Master's degree in Statistics, Data Science, Epidemiology, or related field.

Minimum/General Experience: Five (5) to eight (8) years of experience in healthcare or pharmacovigilance data science.

Duties/Functional Responsibilities: Supports Adverse Events Monitoring by applying advanced analytical, statistical, and machine learning techniques to identify, analyze, and interpret safety signals from large and complex datasets related to drug, biologic, device, or food product adverse event reports.

Develops and applies quantitative methods — including disproportionality analysis (e.g., Empirical Bayes Geometric Mean, Proportional Reporting Ratio) — to detect emerging safety signals from adverse event databases such as FAERS, MedWatch, VAERS, or Sentinel.

Acquires, cleans, transforms, and integrates structured and unstructured data from multiple sources, including spontaneous reporting systems, electronic health records (EHRs), claims data, and published literature, to support comprehensive pharmacovigilance activities.

Data Scientist III Minimum Education: Bachelor's or Master's degree in Statistics, Data Science, Epidemiology, or related field.

Minimum/General Experience: Eight (8) or more years of experience in healthcare or pharmacovigilance data science.

Duties/Functional Responsibilities: Leads Adverse Events Monitoring efforts by applying advanced analytical, statistical, and machine learning techniques to identify, analyze, and interpret safety signals from large and complex datasets related to drug, biologic, device, or food product adverse event reports.

Leads the development and application of quantitative methods — including disproportionality analysis (e.g., Empirical Bayes Geometric Mean, Proportional Reporting Ratio) — to detect emerging safety signals from adverse event databases such as FAERS, MedWatch, VAERS, or Sentinel.

Leads the acquisition, cleaning, transformation, and integration of structured and unstructured data from multiple sources, including spontaneous reporting systems, electronic health records (EHRs), claims data, and published literature, to support comprehensive pharmacovigilance activities.

Business Analyst II Minimum Education: Bachelor's degree in Business Administration, Information Systems, Information Technology, Computer Science, Health Informatics, or a closely related field required.

Minimum/General Experience: A a minimum of three (3) to five (5) years demonstrated experience in business analysis, including soliciting customer requirements, tracking, documenting, and reporting on planning, training, and system requirements.

Duties/Functional Responsibilities: Serves as liaison between contractor and government teams to ensure uniformity of understanding of requirements, and designs and reports on questionnaires, surveys, and operational performance metrics.

Demonstrates knowledge of Enterprise Performance Life Cycle (EPLC) and agile development methodologies, and manages requirements/specifications traceability and documentation, preferably using JIRA and SharePoint.

Develops and manages quality plans utilizing one or more of the following quality methodologies: Total Quality Management (TQM), Continuous Improvement, and Benchmarking.

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

Business Analyst III Minimum Education: Bachelor's degree in Business Administration, Information Systems, Information Technology, Computer Science, Health Informatics, or a closely related field required; Master's degree preferred.

Minimum/General Experience: A a minimum of seven (7) to ten (10) years demonstrated experience in business analysis, including soliciting customer requirements, tracking, documenting, and reporting on planning, training, and system requirements, with a senior-level depth of expertise.

Duties/Functional Responsibilities: Serves as a senior liaison between contractor and government teams to ensure uniformity of understanding of requirements, and leads the design and reporting on questionnaires, surveys, and operational performance metrics.

Demonstrates advanced knowledge of Enterprise Performance Life Cycle (EPLC) and agile development methodologies, and leads management of requirements/specifications traceability and documentation, preferably using JIRA and SharePoint.

Leads the development and management of quality plans utilizing one or more of the following quality methodologies: Total Quality Management (TQM), Continuous Improvement, and Benchmarking.

Preferably possesses Information Technology Infrastructure Library (ITIL) Foundation certification, or equivalent, and leads the development and execution of service delivery models.

Software Engineer II Minimum Education: Bachelor's degree in Computer Science, Software Engineering, Information Systems, Information Technology, or a closely related field required; Master's degree preferred.

Minimum/General Experience: Demonstrated specialized experience in analysis, design, or maintenance of complex software systems, including simulations and modeling, client/server architectures, networking techniques and protocols, databases, programming languages, and/or operating systems.

Duties/Functional Responsibilities: Provides expertise in the design, modification, maintenance, and enhancement of information systems, and coordinates with the client to determine requirements to support specific business functions.

Provides interface, as appropriate, to existing systems including legacy systems, to gather/provide needed information and data, and provides training on enhancements, maintenance, and operation of systems.

Manages or assists with the implementation and roll-out of solutions, and develops and applies advanced methods, theories, and research techniques in the investigation and solution of highly complex and advanced software applications and problems.

Demonstrates understanding of the publicly available FDA Quarterly Data Extract (QDE) policies, processes, and procedures, and experience with log analyses, firewall troubleshooting, configuration patch deployments, troubleshooting subsystems, data call support, OS patches, and VDDs.

Demonstrates experience in configuring, customizing, and implementing the proposed COTS Pharmacovigilance solution, and supports workflow setup, configuration, edit check development, COTS administration, and patch deployments.

Software Engineer III Minimum Education: Bachelor's degree in Computer Science, Software Engineering, Information Systems, Information Technology, or a closely related field required; Master's degree preferred.

Minimum/General Experience: Extensive specialized experience in analysis, design, or maintenance of complex software systems, with demonstrated ability to provide work leadership to lower-level employees.

Duties/Functional Responsibilities: Provides senior-level expertise in the design, modification, maintenance, and enhancement of information systems, and coordinates with the client to determine requirements to support specific business functions.

Provides interface, as appropriate, to existing systems including legacy systems, to gather/provide needed information and data, and provides training on enhancements, maintenance, and operation of systems.

Leads the implementation and roll-out of solutions, and develops and applies advanced methods, theories, and research techniques in the investigation and solution of highly complex and advanced software applications and problems.

Demonstrates understanding of the publicly available FDA Quarterly Data Extract (QDE) policies, processes, and procedures, and experience with log analyses, firewall troubleshooting, configuration patch deployments, troubleshooting subsystems, data call support, OS patches, and VDDs.

Leads the configuration, customization, and implementation of the proposed COTS Pharmacovigilance solution, and leads workflow setup, configuration, edit check development, COTS administration, and patch deployments.

May provide work leadership to lower-level Software Systems Engineers.

System Analyst II Minimum Education: Bachelor's degree in Computer Science, Software Engineering, Information Systems, Information Technology, or a closely related field required; Master's degree preferred.

Minimum/General Experience: Demonstrated experience in system analysis, including system design, testing, training, and implementation, with experience performing feasibility studies, Levels of Effort (LOEs), and proof of concepts.

Duties/Functional Responsibilities: Demonstrates experience in system analysis, including system design, testing, training, and implementation, and acts as release manager for all releases by creating version description documents, obtaining approvals, and adhering to technical delivery milestones.

Works with the Functional Subject Matter Expert and Business Analyst to act as the liaison between contractor and government teams to ensure requirements/specifications are uniformly understood and agreed upon.

Demonstrates experience performing feasibility studies, Levels of Effort (LOEs), and proof of concepts, and experience leading code reviews and testing, and performing database ad hoc queries and query optimization.

Manages requirements/specifications traceability and requirements/specification documentation, preferably using JIRA and SharePoint, in compliance with FDA guidelines.

Creates technical design and specification documentation (e.g., System Requirements Specifications (SRS), Target State Diagrams, System Architecture, and System Design and Test Plans), and demonstrates experience with JIRA, Visio, and SharePoint.

System Analyst III Minimum Education: Bachelor's degree in Computer Science, Software Engineering, Information Systems, Information Technology, or a closely related field required; Master's degree preferred.

Minimum/General Experience: Extensive experience in system analysis, including system design, testing, training, and implementation, with advanced experience performing feasibility studies, Levels of Effort (LOEs), and proof of concepts.

Duties/Functional Responsibilities: Demonstrates extensive experience in system analysis, including system design, testing, training, and implementation, and leads release management for all releases by creating version description documents, obtaining approvals, and adhering to technical delivery milestones.

Leads the liaison function between contractor and government teams to ensure requirements/specifications are uniformly understood and agreed upon, working with the Functional Subject Matter Expert and Business Analyst.

Leads feasibility studies, Levels of Effort (LOEs), and proof of concepts, and leads code reviews and testing, and performs database ad hoc queries and query optimization.

Leads management of requirements/specifications traceability and requirements/specification documentation, preferably using JIRA and SharePoint, in compliance with FDA guidelines.

Creates and oversees technical design and specification documentation (e.g., System Requirements Specifications (SRS), Target State Diagrams, System Architecture, and System Design and Test Plans), and demonstrates advanced experience with JIRA, Visio, and SharePoint.

Test Engineer II Minimum Education: Bachelor's degree in Computer Science, Software Engineering, Information Systems, Information Technology, or a closely related field required; Master's degree preferred.

Minimum/General Experience: Demonstrated experience evaluating, recommending, and implementing automated test tools and strategies, with experience in all phases of risk management assessments and software/hardware development.

Duties/Functional Responsibilities: Evaluates, recommends, and implements automated test tools and strategies, and 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, and writes, implements, and reports status for system test cases for testing.

Analyzes test cases and provides regular progress reports, and serves as a 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.

Test Engineer III Minimum Education: Bachelor's degree in Computer Science, Software Engineering, Information Systems, Information Technology, or a closely related field required; Master's degree preferred.

Minimum/General Experience: Extensive experience evaluating, recommending, and implementing automated test tools and strategies, with demonstrated leadership in all phases of risk management assessments and software/hardware development.

Duties/Functional Responsibilities: Leads the evaluation, recommendation, and implementation of automated test tools and strategies, and designs, implements, and conducts test and evaluation procedures to ensure system requirements are met.

Leads the development, maintenance, and upgrading of automated test scripts and architectures for application products, and writes, implements, and reports status for system test cases for testing.

Analyzes test cases and provides regular progress reports, and serves as a senior subject matter specialist providing testing know-how for the support of user requirements of complex to highly complex software/hardware applications.

Leads all phases of risk management assessments and software/hardware development, with emphasis on analysis of user requirements, test design, and test tools selection, and may provide guidance to lower-level Test Engineers.

Management Consultant II Minimum Education: Bachelor's degree in Business Administration, Management, Public Policy, Organizational Development, or a closely related field required; Master's degree preferred.

Minimum/General Experience: A minimum of 5–7 years of experience providing management consulting services, including strategic planning, organizational analysis, process improvement, and stakeholder engagement, with demonstrated leadership in delivering solutions for complex organizational and operational challenges.

Duties/Functional Responsibilities: Leads the assessment, development, and implementation of management consulting strategies and frameworks, and designs, executes, and evaluates organizational improvement initiatives to ensure alignment with client goals and mission requirements.

Leads the development, documentation, and continuous improvement of consulting methodologies, workflows, and deliverables for client engagements, and prepares, implements, and communicates status reports for project tasks and milestones.

Analyzes organizational data, business processes, and performance metrics to provide actionable recommendations, and delivers regular progress reports to leadership and stakeholders on engagement findings and outcomes.

Serves as a senior subject matter specialist providing management and operational expertise in support of complex to highly complex client requirements, with emphasis on process optimization, change management, and strategic decision-making.

Leads all phases of consulting engagements, including needs assessment, solution design, implementation planning, and performance evaluation, and may provide guidance and mentorship to lower-level Management Consultants.

Management Consultant III Minimum Education: Bachelor's degree in Business Administration, Management, Public Policy, Organizational Development, or a closely related field required; Master's degree preferred.

Minimum/General Experience: A minimum of 6–9 years of experience providing management analysis services, including strategic planning, organizational analysis, process improvement, and stakeholder engagement, with demonstrated leadership in delivering solutions for complex organizational and operational challenges.

Duties/Functional Responsibilities: Leads the assessment, development, and implementation of management analysis strategies and frameworks, and designs, executes, and evaluates organizational improvement initiatives to ensure alignment with client goals and mission requirements.

Leads the development, documentation, and continuous improvement of analytical methodologies, workflows, and deliverables for client engagements, and prepares, implements, and communicates status reports for project tasks and milestones.

Analyzes organizational data, business processes, and performance metrics to provide actionable recommendations, and delivers regular progress reports to leadership and stakeholders on engagement findings and outcomes.

Serves as a senior subject matter specialist providing management and analytical expertise in support of complex to highly complex client requirements, with emphasis on process optimization, change management, and strategic decision-making.

Leads all phases of analytical engagements, including needs assessment, solution design, implementation planning, and performance evaluation, and may provide guidance and mentorship to lower-level Management Analysts.

Base Year

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Option Year 1

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Option Year 2

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Option Year 3

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Option Year 4

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Licenses

6-Months Ext.

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IDIQ Total Value