Drug safety public health Coordinator

·Sets work priorities and direction with input from Manager.

·Responsible for the accurate and timely book-in and acknowledgement of adverse event information in compliance with applicable SOPs and guidelines.

·Understand SDEA and global regulatory reporting timelines in order to prioritize cases if needed.

·Perform simple queries of the safety database, e.g. duplicate searches.

·Maintain and manage dept. Safety mailbox, distributing to relevant parties as applicable.

·May perform initial data entry of ICSRs (review, extract, accurately enter AE data from ICSR reports).

·May interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.

·Meet specific data and quality targets for case handling

·Assist with tracking and reconciliation of incoming adverse event reports.

·Coordinate submission of product complaints to the Quality assurance department.

·Participate in department projects, as required and will be cross-trained to handle other functions as deemed necessary

·Recognizes situations that require assistance from more senior staff members and seeks assistance from appropriate internal and external resources.

·Assists Safety Specialists in sending and tracking follow-up letters.

·Remain current with case handling SOPs, guidance documents and database technology

·May assist manager in the preparation of training material and assist in training new employees their functional area.

·May assist manager with writing/reviewing guidelines for their functional area of expertise.

·May assist with other projects as necessary (i.e., study unbinding, reconciliation with vendors, etc)

·Ensures departmental workflow processes and timelines are followed

·Knowledge, Experience and Skills:

·Excellent interpersonal communication skills, both written and oral

·Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).

·Safety database and data entry experience preferred

·Basic understanding of medical and drug terminology preferred