Job Title: Medical Reviewer/Safety Reviewer - A

Location: Columbus, OH

Duration: 12 Months

Job Description:

• 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 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 reviewing protocols, study summary investigator brochures and IND annual updates for safety data verification.
• 0 to 3 Years Experience Level.