Description
The Senior Director of Safety Operations is responsible for Adverse Event reporting operations within the Drug Safety Risk Management Department. This individual will direct the safety operations team in the processing of Individual Case Safety Reports from clinical trials and post marketing sources, submission of ICSRs, ensuring completeness, integrity, and quality of ICSR data. The Senior Director is also responsible for hiring, training, and management of safety operations staff. Additionally, the Senior Director is responsible for the reconciliation of safety data with the clinical database for clinical development programs. Familiarity with regulations regarding solicited adverse event handling is a plus.To find out more about Real please visit www.realstaffing.com