MedDRA Coder: Post-Market Surveillance (Tobacco)

DaMar Staffing

Richmond (VA)

On-site

USD 70,000 - 100,000

Full time

9 days ago

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Job summary

Ampcus Inc. in Richmond, VA is seeking an experienced Medical Coder to support post‑market surveillance and FDA‑regulated adverse event case processing for consumer products, including nicotine and tobacco products.

You will code using MedDRA and assess case seriousness within the client's internal safety database to ensure timely workflow. The role requires proven post‑market surveillance experience, familiarity with FDA reporting timelines, and the ability to work directly in a client's safety

Qualifications

  • Experience in post-market surveillance and adverse event case processing.
  • Direct experience with consumer products, especially nicotine/tobacco products.
  • Knowledge of FDA adverse event reporting timelines.
  • Experience using a client's internal safety database (no third‑party systems).

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).
  • Collaborate with internal safety and regulatory teams to align on case definitions and coding conventions.

Skills

MedDRA coding
Adverse event processing
FDA reporting requirements
Post-market surveillance
Client database navigation

Education

Certified Medical Coder (CPC/CCS) or equivalent

Tools

Internal safety database

Job description

Ampcus Inc. in Richmond, VA is seeking an experienced Medical Coder to support post‑market surveillance and FDA‑regulated adverse event case processing for consumer products, including nicotine and tobacco products.

You will code using MedDRA and assess case seriousness within the client's internal safety database to ensure timely workflow. The role requires proven post‑market surveillance experience, familiarity with FDA reporting timelines, and the ability to work directly in a client's safety

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