Attachment B - Labor Category Descriptions Rev1.pdf

Attachment B

FAERS DMP Labor Category Descriptions

Labor Category

Labor Category Description

General Clerk II

Minimum / General Experience:

• The General Clerk II shall be able to type 40 words per minute (wpm) with a maximum of two errors, familiarity with data entry.

• Understanding of transcribing procedures and relevant state-of-the-art data entry/computer equipment.

• Technical writing experience preferred.

Minimum Education: High School Diploma or equivalent (Associates degree preferred).

Duties / Functional Responsibilities:

The General Clerk II shall be responsible for the following duties and/or functions:

• Inputs data from source documents into a using FDA device per SOP.

• Scans documents, assigns indices, and loads database with image data.

• Prepares source documents (e.g., splitting reports, collating report pages, etc.) for data entry.

• Exercise experience and judgment in selecting procedures to be followed in searching for, interpreting, selecting, or coding items to be entered from a variety of source documents.

• Compile and summarize statistics on reports received for workload planning.

• Occasionally perform repetitive entry of data from standardized source documents.

• Interact with supervisor to ensure that contract deliverables are completed in a timely manner.

• Maintain files and records.

• Develop and maintain SOPs, Work Guides and other reference files.

• Attend team meetings as requested.

General Clerk III

Minimum / General Experience:

• The General Clerk III shall have a minimum of two (2) years of experience performing data entry.

• Must be able to type 40 wpm with a maximum of two errors.

• Advanced computer skills, including ability to interact with technical staff to communicate problems in applications.

• Understanding of transcribing procedures and relevant state-of-the-art data entry/computer equipment.

• Work independently and interact positively with team members.

Minimum Education: High School Diploma or equivalent (Associates degree preferred).

The General Clerk III shall be responsible for the following duties and/or functions:

• Perform data entry of critical medical information submitted on FDA reporting forms from patients, health care professionals, and consumers into the FDA proprietary databases.

• Exercise experience and judgment in selecting procedures to be followed in searching for, interpreting, selecting, or coding items to be entered from a variety of source documents.

• Gathers quality metrics and distributes them per current SOPs.

• Occasionally perform repetitive entry of data from standardized source documents.

• Interacts with other contractor personnel

• Assigns data entry tasks to General Clerks under their supervision.

• Supervise junior General Clerk staff members and interface with client management.

• Contribute as a subject matter expert when data entry Standard Operating

Procedures (SOPs) are updated.

Subject Matter Expert II

Minimum / General Experience:

• The Subject Matter Expert II shall have a minimum of two (2) years of experience in medical, or scientific field.

• Knowledge of the MedDRA dictionary

• Expert knowledge and experience of MedDRA coding using MedDRA® Term

Selection: Points to Consider.

(https://alt.meddra.org/files_acrobat/000571_termselptc_r4_21_mar2021.pdf)

• Knowledge of MedDRA principles and procedures, and experience in coding adverse events in Individual Case Safety Reports (ICSRs).

• Understanding of medicinal products to be able to identify product names in an ICSR and code to a medical product dictionary like WHO Drug Dictionary.

Minimum Education: Bachelor’s degree (Master’s degree preferred) in a medical profession (e.g., physician, pharmacist, nurse, etc.); MSSO Certification preferred.

The Subject Matter Expert II shall be responsible for the following duties and/or functions:

• Perform coding of medicinal products, manufacturer, and adverse event terms using the appropriate dictionary and resources as per SOPs.

• Perform quality control and quality assurance procedures to ensure appropriate selection of MedDRA codes.

• Verify medical code and data entry.

• Provide feedback regarding quality of work and deficiencies to data entry staff.

• Resolve problems related to coding of products and events, including data entered text by the personnel.

• Assist in the development of Standard Operating Procedures.

• Assist lower-level personnel in task activities.

• Perform quality assurance on data entered into the FAERS system.

Expert III

Minimum / General Experience:

• The Subject Matter Expert III shall have a minimum of three (3) years of experience in medical or scientific field.

• Knowledge of the MedDRA dictionary

• Expert knowledge and experience of MedDRA coding using MedDRA® Term

Selection: Points to Consider.

(https://alt.meddra.org/files_acrobat/000571_termselptc_r4_21_mar2021.pdf)

• Knowledge of MedDRA principles and procedures, and experience in coding adverse events in Individual Case Safety Reports (ICSRs).

• Understanding of medicinal products to be able to identify product names in an ICSR and code to a medical product dictionary like WHO Drug Dictionary

• Ability to train, oversee, and help team members in performing coding activities

• At least 2 years of managerial experience preferred. Experienced in using project management tools such as MS-Project, spreadsheets, and reporting tools.

Minimum Education: Bachelor’s degree (Master’s or Doctorate degree preferred) in a medical profession, (e.g., physician, pharmacist, nurse, etc.); MSSO Certification preferred.

The Subject Matter Expert III shall be responsible for the following duties and/or functions:

• Perform coding of medicinal products, manufacturers, and adverse event terms using the appropriate dictionary and other resources as per SOPs.

• Perform quality control and quality assurance procedures to ensure appropriate selection of MedDRA codes.

• Verify medical code and data entry.

• Provide feedback regarding quality of work and deficiencies to data entry staff.

• Resolve problems related to coding of products and events, including data entered text.

• Assist in the development of Standard Operating Procedures.

• Assist lower-level personnel on tasks and activities.

• Perform quality assurance on data entered into the FAERS system.

• Improve and resolve system and process-related problems.

• Train, oversee, and help Subject Matter Experts II resolve coding issues.

• Assists in administering and overseeing an FDA approved MedDRA coding training program.

• Assist in developing long term and short-term plans and activities to improve coding productivity.

• Demonstrate oral and written communication skills.

• Interface with internal users as well as external stakeholders.

• Manage functional task activities and workload of lower-level personnel.

https://alt.meddra.org/files_acrobat/000571_termselptc_r4_21_mar2021.pdf

Expert IV

Minimum / General Experience:

• The Subject Matter Expert IV shall have a minimum of four (4) years of experience in medical or scientific field.

• Knowledge of the MedDRA dictionary

• Expert knowledge and experience of MedDRA coding using MedDRA® Term

Selection: Points to Consider.

(https://alt.meddra.org/files_acrobat/000571_termselptc_r4_21_mar2021.pdf)

• Knowledge of MedDRA principles and procedures, and experience in coding adverse events in Individual Case Safety Reports (ICSRs).

• Understanding of medicinal products to be able to identify product names in an ICSR and code to a medical product dictionary like WHO Drug Dictionary

• Ability to train, oversee, and help team members in performing coding activities

• Effective communicate skills with all staff members, project management team and stakeholders.

• Possess at least 2 years of managerial experience. Experienced in using project management tools such as MS-Project, spreadsheets, and reporting tools.

Minimum Education: Bachelor's Degree (Master's or Doctorate Degree preferred) in a medical profession, (e.g., physician, pharmacist, nurse, etc.); MSSO Certification preferred.

The Subject Matter Expert IV shall be responsible for the following duties and/or functions:

• Perform coding of medicinal products, manufacturers, and adverse event terms using the appropriate dictionary and other resources as per SOPs.

• Perform quality control and quality assurance procedures to ensure appropriate selection of MedDRA codes.

• Verify medical code and data entry.

• Provide feedback regarding quality of work and deficiencies to data entry staff.

• Resolve problems related to coding of products and events, including data entered text.

• Assist lower-level personnel on task and activities.

• Perform quality assurance on data entered into the FAERS system.

• Improve and resolve system and process-related problems.

• Demonstrate oral and written communication skills.

• Train, oversee, and help Subject Matter Experts II, III, IV resolve coding issues.

• Analyze data entered/submitted, identify coding issues to improve coding process.

• Administer and oversee FDA approved Coding Training program.

• Develop long term and short-term plans and activities to improve coding productivity.

• Refer complex problems regarding coding and data entered to FDA Onsite

Representative to resolve, as needed.

• Provide clear and effective communication with all staff members, project management team and stakeholders.

• Manage functional task activities and workload of lower-level personnel.

Pharmacist Minimum / General Experience:

• The Pharmacist must possess strong current clinical/therapeutic knowledge.

• Effective communicate skills with all staff members, project management team and stakeholders.

• Familiar with a wide range of products on the market regulated by different FDA

Centers.

• Knowledge of MedDRA Dictionary/Coding using MedDRA® Term Selection: Points to Consider, experience preferred.

(https://alt.meddra.org/files_acrobat/000571_termselptc_r4_21_mar2021.pdf)

• Understanding of FDA regulated products to be able to identify product names in an ICSR and code to a medical product dictionary like WHO Drug Dictionary.

• Experience in public health preferred.

Minimum Education: Pharm.D. degree and current Pharmacy registration and up-to-date license in any of the United States required. Other advanced degree/training in public health preferred.

The Pharmacist shall be responsible for the following duties and /or functions:

• Apply clinical and product knowledge in reviewing and triaging incoming Direct reports to the appropriate FDA Center(s) based on product types and safety events.

• Annotate reports as necessary to clarify key data elements such as product names and ICSR narrative.

• Prioritize urgent reports as needed and directed by FDA onsite representative.

• Interpret unclear hand-written reports, as necessary.

• Provide clear and effective oral and written communication to the team members.

• Demonstrate strong knowledge of a wide variety of products under FDA regulation and unapproved products.

• Keep up to date with new products on the market and reporting regulations.

• Help train other triaging pharmacists, as needed.

• Contribute to maintaining/updating SOP, as needed.

• Respond to data request with regards to triaging, as needed.

• Interact with other contracting personnel in registration, data entry, and coding, as necessary, to ensure the highest quality of data capturing from reports.

• Work with Central Triage Unit (CTU) staff to make sure acknowledgment letters are sent out in a timely fashion.

• Consult with the FDA Onsite Representative when encountering unusual reports, data elements, or public health incidents.

Program Manager

Minimum / General Experience:

• The Program Manager must have a proven working experience in project management and minimum of four (4) years of experience in the Health Science or Information Management field or equivalent experience.

• Excellent client-facing and internal communication skills.

• Excellent written and verbal communication skills.

• Solid organizational skills including attention to detail and multi-tasking skills.

• Strong working knowledge of Microsoft Office.

Minimum Education: Bachelor’s (BA/BS)/Associates degree is required. A Bachelor’s (BA/BS)/Associate’s degree in the Health Science or Information Management field is preferred; Project Management Professional (PMP) certification preferred.

The Program Manager shall be responsible for the following duties and/or functions:

• Coordinate Internal Resources and third parties/vendors for the flawless execution of projects.

• Ensure that all projects are delivered on-time, within scope and within budget.

• Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility.

• Ensure resource availability and allocation.

• Prepare detailed project plan to monitor and track progress.

• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques.

• Measure project performance using appropriate tools and techniques.

• Report project status and escalate risks to management as needed.

• Successfully manage the relationship with the client and all stakeholders.

• Perform risk management to minimize project risks.

• Establish and maintain relationships with third parties/vendors.

• Create and maintain comprehensive project documentation.

• Attend Team meetings as requested.

Project Manager III

Minimum / General Experience:

• The Project Manager must have a proven working experience in project management and a minimum of four (4) years of experience in the Health Science or Information Management field or equivalent experience.

• Excellent client-facing and internal communication skills

• Excellent written and verbal communication skills

• Solid organizational skills including attention to detail and multi-tasking skills

• Strong working knowledge of Microsoft Office

Minimum Education: Bachelor’s (BA/BS)/Associate’s degree is required. A Bachelor’s (BA/BS)/Associate’s degree in the Health Science or Information management field is preferred; Project Management Professional (PMP) certification required.

The Project Manager shall be responsible for the following duties and/or functions:

• Manage and supervise all project/task order functional operations and staffing assignments.

• Represent the Program Manager (ProgM) when required at various meetings, functions, and/or events.

• Prepares necessary management reports prior to delivery to ProgM.

• Responsible for collection and reporting of statistical data from his/her respective project.

• Responsible for the maintenance of the project’s database and related IT systems.

• Maintain budget compliance and documentation.

• Ensure that program objectives are met on time and within budget.

• Successfully perform project financial forecasting, utilize financial tools in Excel, and collaborate with the finance and accounting department when applicable.

• Ensure and enforce compliance with the Contract’s terms and conditions.

• Perform quality control/quality assurance inspections to ensure that all performance requirements are met or exceeded.

• Manage and monitor project risks and propose solutions to ensure success.

• Oversees separate initial and ongoing comprehensive training programs for data entry, scanning, quality control, and MedDRA coder personnel.

• Evaluate staff performance and ensure that all project staff receives regular performance reviews.

• Organize, supervise and train the project staff and direct the execution of the business functions of the project.

• Maintain continuous surveillance on project and milestones.

Analyst Coder I Minimum / General Experience:

• The Analyst Coder I must have at least two (2) years experience in using advanced software systems to resolve product/manufacturer coding of adverse event forms using coding terms.

• Experience in coding Individual Case Safety Reports (ICSRs) according to appropriate taxonomies, and established policies and procedures.

Minimum Education: Bachelor’s degree or higher must be in related health science or equivalent experience.

The Analyst Coder I shall be responsible for the following duties and/or functions:

• Ensure the accuracy of data entered into critical fields according to the

Standard Operating Procedures (SOPs).

• Code Individual Case Safety Reports (ICSRs) according to appropriate taxonomies, and established policies and SOPs.

• Resolve problems related to data entry.

• Performs data entry functions as needed.

• Provides quality assurance of the entered data providing critical feedback to data entry staff using a database designed to capture, track, and report errors.

Analyst Coder II Minimum / General Experience:

• The Analyst Coder II must have at least three (3) years experience and proficiency in the use of advanced software systems to resolve product/manufacturer coding of adverse event forms using coding terms.

• Experience in coding Individual Case Safety Reports (ICSRs) according to appropriate taxonomies, and established policies and procedures.

• Possess experience interfacing with internal users as well as external stakeholders.

• Apply and use project management tools such as MS Projects, spreadsheets, etc.

• Use and direct personnel to code from Adverse Event Report forms or images of these forms into a relational database using coding terminology

• Review and retrieve system data, match output with specifications in accordance with Standard Operating Procedures and resolve discrepancies.

• Manage functional task activities and lower-level personnel.

Minimum Education: Bachelor’s degree or higher must be in related health science or equivalent experience.

The Analyst Coder II shall be responsible for the following duties and/or functions:

• Ensure the accuracy of data entered into critical fields according to the

Standard Operating Procedures (SOPs).

Technology Consultant

Minimum / General Experience:

• The Technology Consultant must have experience developing, researching, coordinating, managing, and implementing solutions for emergent problems.

• Relevant Expertise includes (but is not limited to) experience in

Microsoft Windows Operating System at the administrator level, knowledge of relational databases, basic understanding of TCP/IP networks, Microsoft SharePoint, Microsoft Power Apps, modern dashboard applications like Qlik or Tableau, advanced Microsoft Excel Macro’s and ability to work with higher level technical staff, troubleshooting, identified performance issues.

• Experience as an advanced (Tier 2 or above) helpdesk person.

Minimum Education: Applicable certifications (A+, Microsoft MCSA) or equivalent experience.

The Technology Consultant shall be responsible for the following duties and/or functions:

• Provide specialized analysis and solution development services.

• Capable of providing consulting technical help and analysis in matters such as work-load staffing models, Optical Character Recognition or technical analysis and visualization of data entry processing

• Develop and implements IT projects, as directed.

• Provide direction and leadership to assigned personnel.

• Provide on the job training on newly implemented systems, and trouble shooting.

• Establishes and implements policies, procedures, and standards, and ensures their conformance to information systems objectives.

• Train users on system operations.

• May be required to interact with FDA staff or contractors’ staff, as needed

• Code Individual Case Safety Reports (ICSRs) according to appropriate taxonomies, and established policies and SOPs.

• Resolve problems related to data entry.

• Performs data entry functions as needed.

• Provides quality assurance of the entered data providing critical feedback to data entry staff using a database designed to capture, track, and report errors.