Medical Coder

Ampcus Inc. • Richmond, VA

23h • Onsite

About The Position

Ampcus Inc. is 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.

Requirements

• 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).

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed