Senior Clinical Safety Data Scientist (19-00887) – NJ – Woodcliff Lake

DESCRIPTION OF SERVICES REQUIRED:

Under the supervision and guidance of a manager, apply clinical/medical background to review medical conditions; assist and perform coding using a standard medical dictionary (MedDRA, WHODD); perform reconciliation between clinical database and CIOMS; review patient records to identify discrepancies, inconsistencies, or missing data; review AE, SAE cases as directed. Perform review of protocol and CRF in relation to coding and evaluation of safety data.

Logical thinking in grouping of MedDRA terms and medications for use in data analysis.
Performs all duties according to company policy and regulations and guidance. Performs other duties assigned by the head of Onc Coding or its manager. No travel required.

Quantitative analysis – Generate clinical queries on subjects that met the criteria to have a narrative. Generate clear and brief narratives in accordance to the minimum requirement for regulatory submission Performs a comprehensive review for the all the reported and coded terms. To assure the presence of all coding targets not limited to LLT, PT and SOC and Trade name , Preferred Name ATC 2 and ATC 4 and their respective dictionary versions.

Qualitative analysis – Ensures that relevant data is recorded in the clinical database. Evaluates coding consistency and adequacy. Ensures that the selected codes accurately reflect the term as provided by the investigator. Reviews the codes for ICH compliance and adherence to coding guidelines and conventions. Evaluates the narrative index table if this met the minimum requirement for the narrative in preparation to the generation of narratives for inclusion in the regulatory submission.

QUALIFICATIONS:
Medical Degree, Physician-Assistant or PharmD or graduate of adequate health care related course with commensurate experience in use of dictionaries in Clinical trial setting. 5 plus years’ experience.
– Educational background in medical field with strong understanding of pathophysiology of diseases.
– Strong knowledge of medical terminology, ability to apply to clinical coding using standard medical dictionary
– Knowledge of Central coding a plus, if not will train
– Experience with INFORM is a plus, otherwise ability to use/learn complex computer system
– – Knowledge of Oncology Clinical trial Study is a plus, or ability to learn and apply experience in the area of clinical research
– Computer proficiency and Expertise on use of Excel and word
– Strong oral and written communication skills
– Self motivated, pro-active, and quick learner-
Source: Job Diva – Job Listing

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