Specialist II PSS

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.
Essential Job Duties:

• Manage the receipt, processing and quality review of expedited safety reports (ESRs) to Japan PMDA. This includes, but is not limited to
• maintenance of adverse event tracking systems
• set-up and maintenance of project files, core process files and central safety files
• contact with Regulatory Authorities, project teams and with clients to support safety reporting activities
• 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:
• entry of safety data onto adverse event database(s) and tracking systems
• review of adverse events for completeness, accuracy and appropriateness for expedited reporting
• write patient narratives
• code adverse events accurately using MedDRA
• determine expectedness/listedness against appropriate label
• identifies clinically significant information missing from initial reports and ensures its collection
• ensure case receives appropriate medical review
• prepare follow-up correspondence consulting the medical staff accordingly.
• ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
• reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and the Company's project personnel, if required, within study specified timelines
• Maintain a strong understanding of the Company's safety database conventions or client specific database conventions, as appropriate.
• Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
• Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events
• Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).
• Work with Data Management or client on reconciliation of safety databases.
• 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 less experienced safety staff in all aspects of case-handling, adverse event reporting.
• Maintains a comprehensive understanding of Company Safety’s Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
• Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact Safety.
• Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.
• Build and maintain good PSS relationships across functional units.
• Demonstrate role-specific Competencies on a consistent basis.
• Demonstrate company Values on a consistent basis.
• Begin to develop a good knowledge of contract assumptions; identifying out of scope work.
• Read and understand Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
• Begin participating in project teams and client meetings as appropriate.
• Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
• Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
• Assist in the co-ordination of endpoint committees, as required.
  

Any other duties as assigned by management.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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