Medical Reviewer / Safety Reviewer 9/8/2016

AbbVie Inc. North Chicago, IL

Company
AbbVie Inc.
Job Classification
Full Time
Company Ref #
29680315
AJE Ref #
576120519
Location
North Chicago, IL
Job Type
Regular

JOB DESCRIPTION

APPLY
* REVIEWS SAFETY-RELATED DATA FROM CLINICAL TRIALS FOR CONTENT, QUALITY, ADHERENCE TO REGULATORY GUIDANCE AND PROTOCOLS
* Triages SAE information in order to fulfill timely reporting according to the authority/regulatory requirements
* Participates in applicable safety surveillance activities for assigned products
* Collects, analyzes, and triages AEs including reporting SAEs to IND safety
* Assessment of AE coding for consistency and accuracy of coding
* Medical review of safety-related CRFs and labs, including communication with Study Physicians
* Interface with study manager, CROs, CRAs, Data Management, PV to assure query resolution
* Creation of narratives of SAEs and other identified AEs of interest in accordance with accepted standards and with minimal revision required upon review
* Broader knowledge of ICH/FDA regulations and guidelines affecting drug safety issues preferred. Computer proficient (Windows, Word, Excel)
* ABLE TO PRESENT ADVERSE EVENT DATA, ORALLY AND IN WRITING
* MUST BE AN RN