Safety Science Coordinator I

Key Responsibilities

• Assist with Clinical Safety and/or PSS operations, including the adverse events process for clinical trials and post-marketing settings.
• Manage and process expeditable adverse events according to required standards and submit them within agreed timelines.
• Provide services to clients as a support function or as a stand-alone business.
• Ensure the quality of service provided to all clients, both internal and external, in a safe and cost-effective manner.
• Comply with legal requirements, including the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3.
• Assist in the processing of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) and submissions.
• Maintain adverse event tracking systems.
• Set up and maintain project files and central files for documentation.
• Assist with reporting ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel within study-specified timelines.
• Ensure all incoming Adverse Event (AE)/Serious Adverse Event (SAE) reports are appropriately logged and forwarded.
• Assist with processing adverse events, including:
• Data entry of safety data onto adverse event tracking systems.
• Writing patient narratives and coding adverse events accurately using MedDRA (for Marketed products, if applicable).
• Assisting in the listedness assessment against appropriate label (for Marketed products, if applicable).
• Generating queries for missing or discrepant information in consultation with medical staff.
• Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners, and Fortrea project personnel within agreed timelines.
• Assist with peer/quality review of processed reports and support with trends and actions.
• Assist in the reconciliation of databases, as applicable.
• Assist in the maintenance of files regarding adverse event reporting requirements in all countries.
• Work within the Quality Management System framework, including Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Prepare and support the coordination of safety study files for archiving.
• Arrange and schedule internal and/or external meetings/teleconferences.
• Train and mentor PSS Assistants or peers in their 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 the quality of data processed.
• Provide administrative support to PSS personnel.
• Perform other duties as needed or assigned.

Requirements & Tech Stack

• MedDRA (for Marketed products, if applicable)
• MS Office and Windows (beneficial)
• Standard office equipment

Qualifications

• B Pharm/M Pharm with 1-2 years of Safety experience or relevant experience.
• PharmD with 0-6 months of Safety experience or relevant experience.
• A one-year residency or fellowship can be considered as relevant experience for PharmD.
• Degree preferred in: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related area.
• Safety experience includes:
• Actual experience processing AE/SAE reports.
• Generating narratives and queries.
• Working within safety databases.
• Experience with regulatory submissions.
• Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in areas such as:
• Medical Affairs.
• Clinical Data Entry and Clinical Data Management.
• Clinical Data Monitoring.
• Regulatory Affairs.
• Quality Assurance.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Speaking: English and local language.
• Writing/Reading: English and local language.

Experience

• Good team player and offer peer support.
• 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.
• Ability to operate standard office equipment.

Physical Demands/Work Environment

• Office Environment