Drug Safety Public Health Coordinator

Drug Safety Public Health Coordinator

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

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

Qualifications

• 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

• BS degree (or equivalent experience) and little to no experience.