Drug Safety Public Health Coordinator

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