Medical Coder

Job Title: Medical Coders

Terms: 12-month Contract

Location: Richmond VA,, 23232/Remote Possible

Post-Market Surveillance and Adverse Event Case Processing Support Requirements

We are seeking vendors with demonstrated expertise in post-market surveillance (PMS) and adverse event (AE) case processing for consumer products, including nicotine and tobacco products, in alignment with FDA reporting requirements.

Scope of Required Services

The selected vendor should have experience and capabilities in the following areas:

MedDRA Coding

• Accurate coding of adverse events and related medical information using the Medical Dictionary for Regulatory Activities (MedDRA).

Case Assessment Activities

• Seriousness Assessment – Determination of whether an adverse event meets regulatory criteria for seriousness.
• Severity Assessment – Evaluation of the intensity of the reported event.
• Expectedness Assessment – Determination of whether the event is expected based on product information and safety documentation.

Reportability Evaluation

• Identification and escalation of potentially reportable serious adverse events associated with consumer, nicotine, and tobacco products in accordance with FDA requirements.

Operational Requirements

These activities represent our core daily operational workload and are critical to ensuring regulatory compliance, timely case processing, and business continuity. Therefore, we require a vendor with proven experience handling high-volume post-market surveillance activities and maintaining consistent service levels.

Workflow and System Integration

Our current process involves the review and processing of daily consumer complaints within our existing internal database and systems.

As such:

• We are seeking resources that can work directly within our established workflow and technology environment.
• We are not seeking outsourced case management platforms or contractor-owned databases.
• The vendor must be capable of integrating seamlessly with our existing processes while adhering to our data management and compliance requirements.

Vendor Qualifications

Preference will be given to vendors that can demonstrate:

• Experience supporting FDA-regulated post-market surveillance programs.
• Expertise in adverse event processing for consumer products, particularly nicotine and tobacco products.
• Strong knowledge of MedDRA coding and regulatory reporting requirements.
• Ability to operate within client-owned systems and databases.
• Scalable operational support to ensure continuity of critical daily activities.