Specialist I Pss

5 months ago

Maidenhead, United Kingdom Fortrea Full time

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.

In this position you will have the chance to assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports).

You will also manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. You will be also responsible for providing this service to clients either as a support function to the client project groups or as stand
- alone business and responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.

Essential Job Duties:

- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:

- o Data entry of safety data onto adverse event database(s) and tracking systems
- o Review of adverse events for completeness, accuracy and appropriateness for expedited reporting
- o Write patient narratives and code adverse events accurately using MedDRA
- o Determine listedness against appropriate label (for Marketed products, if applicable)
- o Identifies clinically significant information missing from the reports and ensures its collection and follow-up
- o Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines
- o Reporting of endpoints to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required, within study specified timelines
- o Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required & as agreed with client during study set-up, within study specified timelines
- Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), 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 Cuthorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines
- Maintain a strong understanding of Fortrea's safety database conventions or client specific database conventions, as appropriate
- Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed
- Begin participating in signal detection and trend & pattern recognition activities, as appropriate
- Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) like Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc.
- Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided
- Support/train/mentor less experienced safety staff in all aspects of case-handling, adverse event reporting
- Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance
- Assist with review and update of Safety Management Plans (SMPs), Reconciliation Plans, and other safety
- specific plans ensuring optimal efficiency
- Participate in Fortrea project team and client meetings, as appropriate
- Prepare and support coordination of safety study files for archiving at completion of projects
- Contribute to root cause analysis, including the CAPA plan development & implementation
- Support Audits and/or inspections preparation
- Assist in review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients, if applicable and coordination of end point committees
- Any other duties as assigned by management.

Education/Qualifications/Certifications and Licenses
- Non-degree + 2 years of Safety experience
- or 4-5 years of relevant experience
- Associate Degree + 2 years of Safety experience
- or 3-4 years of rele

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