Clinical Safety Data Scientist
Woodcliff Lake, NJ Posted: 9/29/2020
A Leading Pharmaceutical Company is seeking a Clinical Safety Data Scientist.
DESCRIPTION OF SERVICES REQUIRED
Under the supervision and guidance of a manager, apply clinical/medical background to review medical conditions; identify clinically important information from safety report that needs to be recorded by the site in the clinical database; review patient records to identify discrepancies, inconsistencies, or missing data; review AE, SAE cases as directed. Advise a better code using a standard medical dictionary (MedDRA, WHODD). Perform review of protocol and CRF in relation to coding and evaluation of safety data.
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. May assists in review of the reported and coded terms.
Qualitative analysis – Provides a clinically meaningful narratives (patient summaries) while following the writing guidelines. 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.
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.
-Performed medical assessment/ medical data review for at least 2 years
- 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-
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