- 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 systemsreview of adverse events for completeness, accuracy and appropriateness for expedited reportingwrite patient narrativescode adverse events accurately using MedDRAdetermine expectedness/listedness against appropriate labelidentifies clinically significant information missing from initial reports and ensures its collectionensure case receives appropriate medical reviewprepare follow-up correspondence consulting the medical staff all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelinesreporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Fortrea project personnel, if required, within study specified timelines
- Maintain a strong understanding of Fortrea'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 Fortrea 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 Fortrea 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.
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Siemens Industry Software (Shanghai) Co., Ltd. Beijing, 中国 PermanentSiemens Digital Industries Software is a leading provider of solutions for the design, simulation, and manufacture of products across many different industries. Formula 1 cars, skyscrapers, ships, space exploration vehicles, and many of the objects we see in our daily lives are b ...
Specialist I PSS - Beijing, 中国 - Fortrea
描述
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.
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.
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