Clinical Safety Scientist

Contract Clinical Safety Scientist in East Hanover, NJ.

 

Responsibilities:  Responsible for performing global safety activities to ensure compliance with international regulatory requirements. The Clinical Safety Scientist will perform the medical and regulatory evaluation of spontaneous marketed adverse event reports and serious adverse event reports (SAEs) from clinical trials. The Clinical Safety Scientist will write the medical case narratives and provide the coding of adverse event terminology and other medical information in accordance with standardized dictionaries for all adverse event reports. The Clinical Safety Scientist will assess the labeling for event terms against the product's U.S. local product labeling for regulatory status for local/international expediting criteria.

 

Requirements:  B.S. or higher degree in Nursing and Pharmacy. Understanding of clinical trial methodology, adverse events reporting standards, medical terminology and FDA regulations. Computer literacy, familiarity with Windows 98 and environment and Oracle database preferred. Excellent communication, interpersonal, organizational, and workload planning skills.

 

Keywords:  SAE, CRS, Regulatory, New Jersey, Clin*, Pharmaceutical, Biotech, CRO