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 · Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred · Demonstrates initiative, teamwork and accountability · Demonstrated success working both independently and in collaboration with others · A quality driven individual with strong attention to detail and accuracy is required · Strong organizational skills, and ability to adapt to change · A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under stick timelines is required. · Ability to follow guidelines and procedural documents · AA or BS degree (or equivalent experience) and little to no experience. · Industry experience in the health, clinical, bio-pharmaceutical, or relevant industries such as, pharmacy technician, nursing assistant is valuable but not required. Rupalim Dutta Clinical Recruiter Integrated Resources , Inc. IT Life Sciences Allied Healthcare CRO Certified MBE | GSA - Schedule 66 I GSA - Schedule 621I DIRECT # 650-399-0896 LinkedIn: www.linkedin.com/in/rupalim-dutta