Clinical Safety Coder IV-Remote
Company: US Tech Solutions
Posted on: January 13, 2022
- 100% remote job
- Coding clinical data for Phase I to IV
- Navigating on excel and MS Team.
- Rave Coder and/or TMS are coding application.
- ATC coding needed.
- Adverse event coding, medical product coding .
- Can navigate between two monitor.
- MedDRA, and WHO -DD is strongly preferred
Please emphasize the following
- Nursing preferred, however will consider PharmD and MD
- Has performed coding for clinical trials versus only
havebackground in PV as a safety specialist
- Has prior experience using Rave Coder and/or TMS. MedCodr a
- Has prior experience actually performing ATC coding (vs
exposure); this is very important
- 100% remote (opens to anywhere in US)
- Ensures accurate and consistentcoding of medical data,
including but not limited to, adverse event verbatim descriptions
and medication data received from global clinical trials across all
clinical areas including identification of prohibited medications
and exclusionary medical history.
- Participates in Centralized Clinical Coding Group (CCCG)
process improvement initiatives and serves as asubject matter
expert and primary coding resource for assigned compounds and
- Primary coding resource for assigned products and studies.
Accurately codes assigned data fields including, but not limited
to,adverse events using MedDRA and concomitant medications using
WHO Drug in accordance with company coding conventions and
- Prepare and manage coding assignments for new studies and
collaborate with clinical team representatives on approach to
coding strategy for assigned products and oversight of assigned
studies including sign off of document as it impacts medical coding
review, product approval, analysis of coded data for safety review
and signal detection and patient safety.
- Identifies when terms or drug names are inadequate, ambiguous
or unclear for coding purposes and direct query generation in such
aspects. Also,identify and resolve coding discrepancies; and review
coding listings for accuracy and consistency.
- Provide Coding training/overview to Clinical team members,
Clinical Research Organizations, Investigators and investigator
sites as needed, in support of clinical trials.
- Bachelor's degree with related health science background
required (e.g. Nursing, Pharmacy). A relevant coding experience
with a minim um of 8+ year drug safety/ pharmacy experience or 8+
years clinical and 8+ years drug Pharmacy experience preferred but
- Must have a strong understanding and utilization of medical
- Experience incoding medical data (adverse events and
concomitant medications) and understanding of the clinical coding
process is preferred. Working knowledge of MedDRA, and WHO -DD is
- Working knowledge ofClinical trial data systems and/or EDC
coding tools is a plus.
- Ability to accurately retrieve data for safety or other
- Must have absolute resolution of medical coding data
completeness regarding all aspects of safety management utilizing
basic knowledge of regulatory guidance's/ practices.
Keywords: US Tech Solutions, Irvine , Clinical Safety Coder IV-Remote, Healthcare , Irvine, California
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