Analyst Coder II
Zimmerman Associates, Inc. (ZAI) is seeking an Analyst Coder II 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 role also involves coordination with internal users and external stakeholders, as well as oversight of coding activities and lower-level personnel. The ideal candidate will have strong analytical skills, attention to detail, and experience with advanced coding systems and healthcare-related data environments.
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.
- Perform data entry functions as needed.
- Provide quality assurance of entered data and deliver 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 three (3) years of experience and proficiency in advanced software systems used to resolve product/manufacturer coding of adverse event forms using coding terms
- Experience coding Individual Case Safety Reports (ICSRs) according to appropriate taxonomies, policies, and procedures
- Experience interfacing with internal users and external stakeholders
- Experience using project management tools such as MS Project, spreadsheets, and similar tools
- Ability to code from adverse event report forms or images into a relational database using coding terminology
- Ability to review and retrieve system data, identify discrepancies, and resolve issues in accordance with SOPs
- Experience managing functional task activities and lower-level personnel
- Strong attention to detail and ability to maintain accuracy in a high-volume environment
- 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 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.