Job Opportunities

Clinical Safety Associates are responsible for:

· Triaging, collecting, monitoring, processing, and distributing the adverse event reports (serious and non-serious Adverse Event(s) ) to sponsor or regulatory authorities and project team within specified timelines

· Generate queries related to serious and non-serious Adverse Event and follow up until resolution.

 · Perform all safety database required functions, e.g data entry, narrative preparation, dictionary management etc, until completion of the case, and retrieve all customized and other regulatory reports.

· Perform 100% Case Report Form Review if specified by the Sponsor

· Perform comparative review of Clinical and Safety database and reconciliation of all adverse events.

· Coordinate with the assigned Clinical Reviewer for the adjudication of Mace and/or endpoint events that require CEC adjudication.

· Provide coverage for serious adverse events reported during non business hours, weekends, and holidays on rotational basis, as required by assigned protocols.

· Perform other safety-related tasks that may be required for specific protocol or due to change in regulatory requirements.

· Follow moral and professional standard for conducting day to day activities.

· Responsible for triaging all reported Serious Adverse Event(s) and UADE reports from study site via telephone or fax copies and document all required information in tracking log.

· Follow internal company Standard Operating Procedures for execution of tasks