Chenega Corporation Business Process Analyst IV - FDA/OSE (Part-Time) in Silver Spring, Maryland
CHENEGA PROFESSIONAL & TECHNICAL SERVICES, LLC
Company Job Title:
Business Process Analyst IV
Chenega Job Title:
Silver Spring, MD
Part-Time, Regular, Hourly, Non-Exempt
THIS POSITION IS CONTINGENT UPON CONTRACT AWARD
Chenega Professional & Technical Services (CPTS) is seeking a Business Process Analyst IV to support the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE). This individual is recognized as an expert in the laws, regulations, guidances, policies, and procedures that govern the work of the review staff and the business needs of the organization, and ensures that system development meets legislative, regulatory, and center policy requirements.
Essential Duties and Responsibilities:(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position)
Responsible for ensuring that the system development is compatible with the organization’s business processes, data standards, and regulatory initiatives.
Perform quality reviews to ensure business requirements specification document is accurate, consistent with FDA laws, regulations and policies, includes all important concepts, meets the writing style requirements of the agency, follows the appropriate template and are written at an appropriate comprehension level for the intended audience.
Provide pharmacovigilance knowledge and guidance to contractor staff, ensuring compliance with industry standards.
Conduct ongoing assessments to confirm that implemented solutions meet business requirements, compliance, and regulations.
Manage communication with all stakeholders (business partners, IT team, service providers) in the project to ensure they are kept aware of the status of all work.
Partner with key staff in the functional areas (e.g. Pharmacovigilance, Risk Management, Premarket Safety Reports, Signal Enhancements, Data Mining, Data Analytics, Data Visualization, and internal process improvements) when appropriate to ensure requirements conform to applicable regulations.
- Other duties as assigned.
Minimum Qualifications:(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)
Bachelor’s/Master’s degree and at least 8 years of experience in the pharmaceutical industry or public health field.
Knowledgeable in all areas of Pharmacovigilance business needs and an expert in guiding data migration, performing dictionary management to ensure the ability of the organization to accomplish the core review work.
Knowledge, Skills and Abilities:
Demonstrable knowledge of the relevant ICH, EU, and FDA guidelines and regulations for clinical trials and post-marketing environments.
Well-versed in International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B (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 MeDRA.
Demonstrate critical thinking skills, sound judgment, attention to detail, and strong organization and communication skills.
- Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.
- Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
The employee will normally work in a temperature-controlled office environment, with frequent exposure to electronic office equipment.
During visits to areas of operations, may be exposed to extreme cold or hot weather conditions. Is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and loud noise.
Chenega Corporation and family of companies is an EOE.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Sexual Orientation/Gender Identity
Native preference under PL 93-638.
We participate in the E-Verify Employment Verification Program.
Organization: Chenega Professional & Technical Services
Title: Business Process Analyst IV - FDA/OSE (Part-Time)
Location: Maryland-Silver Spring
Requisition ID: 1800004183