Job Title: Drug Safety Public Health Coordinator
Duration: 6 Months
Location: Foster City, CA 94404
Job Description:
- 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