Perform medical coding of clinical data such as adverse events, concomitant medications, and medical history using MedDRA and WHODrug global dictionaries as per agreed coding guidelines. This includes reviewing of automatically coded data by a coding tool as well as performing manual coding of data that cannot be auto coded by a coding tool.
Perform review of medical coding completed by CRO or another medical coder.
Perform medical coding and up-versioning for legacy data and pooled data. Ensure coding accuracy and consistency within studies.
Liaise with internal Data Management team as well as CRO Data Management team to resolve any coding related data issues
Further, you:
Contribute to the continuous improvement of processes, tools, technologies, standards, Standard Operating Procedures (SOPs) and other Quality Documents
Who you are:
Industry Experience in the area of medical coding (minimum 7-9 years)
In-depth experience with coding dictionaries such as MedDRA, WHODrug
In-depth experience with coding tools and processes
Fluency in English (oral and written)
Detail orientation with strong prioritization skills
Sound understanding of the activities of trial and development team
Comprehensive knowledge of ICH-GCP, FDA regulations and Good Clinical Practice
