MedDRA Coder - Post-Market Safety & FDA Reporting

Ampcus Inc; Richmond (VA); On-site; USD 60,000 - 80,000; Full time

Job summary

Ampcus Inc. in Richmond, VA, is looking for a motivated Medical Coder to support post‑market surveillance and adverse event case processing. The successful candidate will work directly within the client’s complaint database to ensure error-free, compliant coding of consumer-driven incidents, particularly for nicotine and tobacco products.

This role demands proficiency in MedDRA coding and an understanding of FDA reporting requirements. Qualified candidates will possess significant experience in this field and will play a crucial role in improving product safety and quality.

Qualifications

• Proven experience in post‑market surveillance and adverse event case processing.
• Direct experience with nicotine and tobacco consumer products.
• Expertise in MedDRA coding and event assessments.

Responsibilities

• Perform MedDRA coding on adverse event reports.
• Conduct assessments for each case's seriousness and severity.
• Identify reportable serious adverse events per FDA requirements.
• Process daily consumer complaints in the database.
• Ensure timely case processing for post‑market surveillance.
• Collaborate with safety and regulatory teams.

Skills

Post‑market surveillance experience

MedDRA coding expertise

Seriousness/severity assessments

FDA reporting familiarity

Consumer product knowledge

Education

Certified Medical Coder (CPC, CCS, or equivalent)

Job description

Ampcus Inc. in Richmond, VA, is looking for a motivated Medical Coder to support post‑market surveillance and adverse event case processing. The successful candidate will work directly within the client’s complaint database to ensure error-free, compliant coding of consumer-driven incidents, particularly for nicotine and tobacco products.

This role demands proficiency in MedDRA coding and an understanding of FDA reporting requirements. Qualified candidates will possess significant experience in this field and will play a crucial role in improving product safety and quality.