Integration International Inc

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...