Functional Quality Specialist I

Adverse Events and Product Quality Management:

• Manage and review expeditable adverse events, product quality complaints, and medical information.
• Submit reports to clients and regulatory agencies within agreed timelines.

Process Review and Audit Readiness:

• Assist in process reviews and measure/monitor audit readiness.
• Coordinate client or external audits of assigned projects.

Training and Development:

• Design and track training schedules and materials for new hires and existing team members.

Quality Management:

• Contribute to quality error discussions and process improvements.
• Assist in developing Quality Management Plans for assigned projects.
• Support clients during regulatory inspections with the project team.

Data Analysis and Process Improvement:

• Perform and review data analysis to suggest and drive process improvements.
• Track various types of information and metrics, conduct ongoing QC of defined process steps, and reconcile data from multiple sources.

Medical Information Queries:

• Respond to medical information queries, product quality complaints, and general queries received via telephone, email, fax, etc
• Review recorded information and execute drug safety data management processes.

Safety Data Management:

• Guide safety associates in managing voice calls as required.
• Review and drive strategies for process improvement/excellence.

Regulatory Submissions:

• Review safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging Reports, Investigator Brochures, Clinical Study Reports, etc

General Support Activities:

• Perform additional support activities as assigned.

Who We Are Seeking:

Fortrea is looking for motivated problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. We are committed to revolutionizing the development process to deliver life-changing ideas and therapies swiftly to patients in need.

Why Join Fortrea:

• Embrace a collaborative workspace that nurtures personal growth.
• Make a meaningful global impact in clinical development.
• Join an exceptional team dedicated to innovation and excellence