[Hiring] Assistant II PSS @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 and submit them to the client and regulatory agencies within agreed timelines.
• Provide all clients with appropriate quality of service 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), Periodic Safety Reports (PSRs) and submission, including but not limited to:
• Maintenance of adverse event tracking systems.
• Set-up and maintenance of project files, and central files for documentation.
• Assist with reporting of 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 logged into the departmental tracking application and forwarded to the centralized mailbox.
• Assist with processing of 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).
• Assist in the listedness assessment against appropriate label (for marketed products, if applicable).
• Generate queries for collection of missing or discrepant information in consultation with medical staff, if needed.
• 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 as needed.
• 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 Procedure (SOP), departmental Work Instructions (WIs), etc.
• Prepare and support coordination of safety study files for archiving at completion of projects.
• 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 quality of data processed.
• Provide administrative support to PSS personnel.
• 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 actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
• Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Management, Clinical Data Monitoring, Regulatory Affairs, or 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.

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.