FAQs
What is the primary role of a Safety Science Analyst?
The primary role of a Safety Science Analyst is to perform case intake and triage of incoming safety information or reports, assist with the processing of adverse events, and ensure compliance with regulatory requirements in the context of safety data management.
What specific tasks are involved in processing adverse events?
Tasks involved in processing adverse events include data entry of safety data onto tracking systems, writing patient narratives, coding adverse events using MedDRA, assessing listedness against appropriate labels, generating queries for missing information, and submitting expedited reports to various stakeholders.
What regulatory agencies do we report to?
Reports may be submitted to worldwide regulatory agencies, clients, ethics committees, investigators, and other relevant parties as required based on regulatory and study-specific timelines.
Is experience with MedDRA required for this position?
Yes, familiarity and experience with MedDRA coding for adverse events is important for accurately capturing and reporting safety data for marketed products.
What kind of interpersonal skills are necessary for this position?
Strong communication and collaboration skills are necessary to build and maintain good relationships across functional units and to support compliance with governing regulatory requirements.
Are there opportunities for professional development in this role?
Yes, the role provides opportunities for professional development through engagement with various regulatory and clinical processes, as well as training within the Quality Management System.
What is meant by "Quality Management System framework"?
The Quality Management System framework refers to the set of policies, procedures, and processes used to ensure consistent quality and compliance in operations, including adherence to Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
Is this position eligible for advancement within the company?
Yes, employees in this position have opportunities for advancement within the company based on their performance and contributions.
What kind of documentation will I be responsible for maintaining?
You will be responsible for maintaining supporting files and documentation regarding adverse event reporting requirements in all applicable countries, as well as project documentation for case studies.
Does Fortrea offer an inclusive work environment?
Yes, Fortrea is committed to diversity and inclusion in the workplace and does not tolerate harassment or discrimination of any kind.