Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity.
Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Senior Data Coding Specialist encodes terms reported as adverse events and medical history as well as prior and concomitant medications using industry accepted dictionaries such as MedDRA and WHOdrug.
Essential Functions of the Job (Key responsibilities)
Code in accordance with departmental coding conventions and company SOPs.
Code clinical data for all in-house studies; identify inadequate data or unclear medical terms and medications and generate coding queries.
Review coding documentation in regards to study start-up documents, coding configuration specifications and dictionary version use.
Identify and troubleshoot operational issues with the coding tool and integration-related issues; liaise with EDC vendor(s) and CROs to assure all coding activities are conducted within timelines and according to specifications.
Perform quality checks and data review to ensure coding consistency.
Perform clinical literature search to address coding issues and to facilitate coding processes.
Provide coding advice related to process and company standards to data management group.
Develop coding specifications and UAT requirements for coding tool and test according to UAT Plan.
Collaborate with medical monitors, clinical and data management team members, as required, to ensure the timely processing of coding, according to project timelines.
Participate in the development and maintenance of coding guidelines and coding consistency documents
Assist in interdepartmental training of new staff as needed.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor’s degree in health science. Commensurate experience will be considered.
5+ years industry experience in pharmacovigilance, clinical research, and / or clinical data management required, and 4 years coding experience.
Expertise in medical terminology & coding is essential.
Excellent written and oral skills and demonstrated ability to work both independently and within cross functional teams.
Experience with MedDRA and WHODD is required.
Strong attention to detail and a commitment to high quality work.
Experience in Oncology is preferred.
Disclaimer : The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.