Description
Safety Coordinator
• Provides administrative support to the team.
• Intakes, triages and disseminates information related to potential adverse events to appropriate members of the team.
• Will be responsible for submission support duties including updating the safety database and ensuring that submissions are made to the correct agencies.
• Will have a basic understanding of global regulatory reporting requirements.
• Demonstrates proficiency in current duties, with high-quality work output that requires limited corrections.
• Can be relied on to routinely and accurately assess potential cases for report-ability.
• Demonstrates an ability to effectively take on more responsibilities, such as writing simple case narratives that will are not required to be submitted to regulatory agencies.
• Individuals must show a willingness and ability to learn and apply new knowledge to their current role.
• Proven ability to handle high volumes of work accurately and rapidly
Job Responsibilities
• 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.
• 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
• Responsible for regulatory submissions of ICSR and aggregate reports.
• Assist with tracking and reconciliation of incoming adverse event reports, Investigator letter distribution, and regulatory submissions.
• 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
• Ensures compliance with SDEA and other global regulatory reporting requirements for ICSR
• 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