Medical Coder

About the Role:
We are seeking experienced Medical Coders to support post-market surveillance and adverse event case processing tied to FDA reporting requirements. This is a unique, high-priority role supporting consumer products, including nicotine and tobacco products. You will work directly within our existing complaint database-not a contractor-managed system-to ensure timely continuity of daily operational workflows.

Key Responsibilities:

• Perform MedDRA coding on adverse event reports derived from consumer complaints.
• Conduct seriousness, severity, and expectedness assessments for each case.
• Identify potentially reportable serious adverse events in compliance with FDA requirements.
• Process daily consumer complaints within the client's proprietary database (no external data management solutions).
• Ensure accurate and timely case processing to support post-market surveillance continuity.
• Collaborate with internal safety and regulatory teams to align on case definitions and coding conventions.

Required Experience & Skills:

• Proven experience in post-market surveillance and adverse event case processing.
• Direct experience with consumer products, specifically nicotine and tobacco products (required).
• Expertise in MedDRA coding, seriousness/severity/expectedness assessments, and identification of reportable events.
• Familiarity with FDA reporting requirements for adverse events.
• Ability to work directly within a client's internal safety database (no third-party system management).

Preferred Qualifications:

• Certified Medical Coder (e.g., CPC, CCS, or equivalent) preferred but not required if deep relevant experience is demonstrated.
• Prior experience with consumer health, OTC, or regulated consumer goods.
• Understanding of regulatory expectations for adverse event reporting timelines.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.