Medical Reviewer/Safety Reviewer

Description Ockham is a global provider of resources to the Biotechnology and Pharmaceutical Industry. We work with companies involved with clinical trials and other market approval processes to help them deliver their products on time and on budget.  One of our clients in North Chicago, IL is seeking a Medical Reviewer/Safety Reviewer.  This is a contract position.

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 organize the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Events 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 to 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.

Requirements RN/BSN