[Hiring] Safety Science Coordinator I @Fortrea

Role Description

Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process:

• Manage and process expeditable adverse events to the required standard.
• Submit adverse events to clients and regulatory agencies within agreed timelines.
• Provide quality service to clients in a safe and cost-effective manner.
• Comply with legal requirements of the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3.

Summary of Responsibilities:

• Assist in the processing of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs), including:
• Maintenance of adverse event tracking systems.
• Set-up and maintenance of project files and central files for documentation.
• Assist with reporting ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, and investigators within specified timelines.
• Log incoming Adverse Event (AE)/Serious Adverse Event (SAE) reports into the tracking application.
• Process adverse events, including:
• Data entry of safety data onto tracking systems.
• Write patient narratives and code adverse events accurately using MedDRA.
• Assist in the listedness assessment against appropriate label.
• Generate queries for missing or discrepant information in consultation with medical staff.
• Submit expedited SAE reports to clients, Regulatory Authorities, and other stakeholders within agreed timelines.
• Assist with peer/quality review of processed reports and support with trends and actions as needed.
• Assist in the reconciliation of databases.
• Maintain files regarding adverse event reporting requirements in all countries.
• Work within the Quality Management System framework, including SOPs and departmental Work Instructions.
• Prepare and support coordination of safety study files for archiving at project completion.
• Arrange and schedule internal and/or external meetings/teleconferences.
• Train and mentor PSS Assistants or peers in day-to-day activities.
• Build and maintain good PSS relationships across functional units.
• Ensure compliance of operations with governing regulatory requirements and applicable study/project specific plans.
• Assume responsibility for quality of data processed.
• Provide administrative support to PSS personnel.
• Perform all other duties as needed or assigned.

Qualifications

• Non-Degree or 1-2 years of Safety experience or relevant experience.
• Associate degree or 6 months to 1 year of Safety experience or relevant experience.
• BS/BA with 0-6 months to 1 year of Safety experience or relevant experience.
• MS/MA with 0-6 months of Safety experience or relevant experience.
• PharmD with 0-6 months of Safety experience or relevant experience.
• For PharmD, a one-year residency or fellowship can be considered as relevant experience.
• Degree preferred in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
• Safety experience includes processing AE/SAE reports, generating narratives, and working within safety databases.
• Relevant experience includes pharmaceutical, biotechnology, or CRO industry experience in related areas.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Speaking: English and local language.
• Writing/Reading: English and local language.

Requirements

• Good team player and offer peer support as needed.
• Ability to set priorities and handle multiple tasks.
• Attention to detail.
• Good written and verbal communication skills.
• Logical and spelling skills, preferably with an aptitude for handling and proof-reading numerical data.
• Good keyboard skills, preferably with knowledge of MS Office and Windows.
• Ability to operate standard office equipment.

Physical Demands/Work Environment

• Office Environment or remote.