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 • 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 • JD – Drug Safety & Public Health, Operations • 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. Additional Information All your information will be kept confidential according to EEO guidelines.