Analyst Coder I
Zimmerman Associates, Inc. (ZAI) is seeking an Analyst Coder I to support adverse event reporting and safety data management activities within the FDA Adverse Event Reporting System (FAERS) database, including the Data Management Platform (DMP). This position is responsible for coding and quality review of Individual Case Safety Reports (ICSRs), ensuring accuracy, consistency, and compliance with established taxonomies, policies, and Standard Operating Procedures (SOPs).
The ideal candidate will possess strong analytical skills, attention to detail, and experience working with safety reporting systems and healthcare-related data.
Duties / Functional Responsibilities
- 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.
- Attend team meetings as requested.
Required Qualifications
- Bachelor's degree or higher must be in related health science or equivalent experience
- Minimum of 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
- Strong attention to detail and ability to maintain accuracy in a high-volume environment
- Ability to analyze and resolve data entry and coding issues effectively
- Strong organizational and communication skills
Preferred Qualifications
- Experience working with the FDA Adverse Event Reporting System (FAERS) database and/or Data Management Platform (DMP) or similar safety reporting systems
- Experience working in pharmacovigilance, healthcare, clinical research, or drug safety environments
- Familiarity with adverse event reporting systems and medical terminology
- Experience performing quality assurance reviews and data validation activities
Equal Opportunity Employer Statement
Zimmerman Associates, Inc. is an Equal Opportunity Employer. In accordance with federal and state laws, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, veteran status, or any other legally protected status.