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Job Title: Adverse Experience Reporting Coordinator- III (Senior)
Category:  Professional & Business Operations
Description: 
Receives reportable event information [ Serious Adverse Events (SAE) ] creates, reviews and manages case reports for these events. Submit to regulatory group to meet reporting timeframes and ensure compliance with regulations. Supports the clinical team in the medical review of reportable event data, ensures that all information needed to support a sound medical case is obtained. Generates safety queries to the study sites to resolve gaps and discrepancies in the data related to reportable events. As a member of the Medical Monitoring Team (MMT), provides individual case report input during MMT review of cumulative/aggregate review of SAE/ECI data. Reconciles critical datapoints between clinical and safety database regarding reportable events and ensures inclusion of the 15 Quality Attributes 
Requirements: 
• BA/BS Degree • Nursing degree a plus

• Prior experience in SAE reporting and management required

• At least 1 year experience in drug development and/or health sciences

• Strong understanding of scientific process and familiarity with medical and statistical concepts

• Strong analytic skills and ability to make data driven decisions

•Good communication (verbal and written) and computer/database management skills

• Experience as a member/contributor to cross functional teams. 
Location  Rahway , NJ
Minimum Experience (yrs):  2+
Required Education:  Not Specified


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