As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Specialist II, Patient Safety Solutions- Post Marketing

This is a remote, home based role, in the US.

Job Summary :

e., unsolicited reports).

Manage and process adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed / stated timelines.

Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business.

Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.

He / she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992 / 3 as documented in the Company’s Health & Safety Manual The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.

Assist in the processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) submission, and processing of adverse events, 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 the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines

Ensure all incoming Adverse Event (AE) / Serious Adverse Event (SAE) reports are appropriately logged into the departmental tracking application and forwarded to the centralized mailbox

Data entry of safety data onto adverse event tracking systems

Write patient narratives and code 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 its collection of missing or discrepant information in consultation with medical staff, if needed

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 but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate

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 the 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

Experience Required :

US-based Registered nurse with significant clinical experience and more than 5 years of PV / Safety experience

• 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 Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance

Pay Range : $75,000 - $85,000 k USD

Benefits : All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees / certifications, as well as internal equity and market data.

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including : Medical, Dental, Vision, Life, STD / LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.

Last updated : 2024-05-25