Medical Reviewer / USA

Purpose:
Responsibilities include medical review, which involves in- house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.

Job Description:
* Collects, analyzes and triages adverse events and reviews safety-related data from clinical trials including adverse event reporting
* medical review including labs, vital signs, cardiac, medical history
* Participate in safety surveillance activities for assigned products, including assisting with regulatory responses and ad hoc data analysis
* Creation of narratives of serious adverse events and other identified adverse events of interest in accordance with accepted standards and with minimal revision required upon review.
* Adherence to regulatory guidance, Protocols, and departmental processes under minimum supervision