PLEASE NOTE: This role is 100% administrative. Candidates will spend 50% of their time processing safety cases, and 50% entering/tracking drug safety data.
Assist in the design, training, implementation, and coordination of trial-specific safety reporting and data reconciliation processes and procedures under direction of Safety Surveillance Management. Participate in daily processing of safety data across multiple trials; and create, update, and maintain documentation for review by sponsors and trial management. Participate in the development and implementation of Safety Surveillance processes and standards.
Work Performed
Participate in discussions and assist in the design and implementation of trial specific safety reporting processes under direction of the Medical Monitor, Safety Surveillance Manager, or Safety Surveillance Associate III. Define reporting criteria and associated processes.
Draft and maintain trial-specific reporting plans, processes, and associated form...