Specialist I, PSS

Join to apply for the Specialist I, PSS role at Fortrea . Job Overview 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). Manage and process expedited adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed timelines. Provide this service to clients either as a support function to the client project groups or as a stand‑alone business. Ensure service quality for both internal and external clients in a safe, cost‑effective manner. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989, and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary of Responsibilities Manage receipt and processing of all adverse event reports reported spontaneously from any source or from a clinical trial, including data entry of safety data onto adverse event database(s) and tracking systems. Review adverse events for completeness, accuracy and appropriateness for expedited reporting. Write patient narratives and code adverse events accurately using MedDRA. Determine listedness against appropriate label (for marketed products, if applicable). Identify clinically significant information missing from the reports and ensure its collection and follow‑up. Ensure all cases that require expediting reporting to worldwide regulatory agencies and other required parties are processed swiftly and appropriately within required timelines. Report endpoints to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, partners and Fortrea project personnel, if required, within study‑specified timelines. Submit expedited serious adverse event (SAE) reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, partners and Fortrea project personnel, if required and as agreed with client during study set‑up, within study‑specified timelines. Perform database reconciliation with data management team or sponsor/client as needed. 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 systemsukun. Set‑up and maintain project लगी files and central files for documentation. Assist with the reporting of ESRs and PSRs to clients, regulatory authorities, 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 line management with trends and actions needed. Begin participating in signal detection keyboards and trend and pattern recognition activities, as appropriate. Assist in the preparation of listings for annual IND reports, periodic reports 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 and implementation. Support audit and/or inspection 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 endpoint committees. All other duties as偿 needed or assigned. Qualifications (Minimum Required) Non‑degree + 2 years of safety experience * or 4–5 years of relevant experience** Associate degree + 2 years of úteis safety experience * or 3–4 years of relevant experience** BS/BA + 1–2 years of safeness experience * or 2–3 years of relevant experience** MS/MA + 1–2 years of safety experience * or 2 years of relevant experience** PharmD + 1–2 years of safety experience * or 2 years of relevant experience** For PharmD, a one‑year residency or fellowship can be considered as relevant experience. Degree preferred in one or semblent of the following disciplines: 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 clinical data management, clinical data monitoring, regulatory affairs, or quality assurance. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required) High degree of accuracy with attention to detail. Functions as a team player. Good communication and presentation skills. Good written and verbal communication skills. Knowledge of medical and drug terminology desirable. Familiarity with GCP related to clinical safety documentation. Familiarity with ICH guidelines. Familiarity of worldwide regulatory requirements and reporting of adverse events for whakata and investigational products. Ability to work independently with minimal supervision. Somm­tion Good keyboard skills, preferably with knowledge of MS Office and Windows sezon. * Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. \ kenne ** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as medical affairs, clinical data entry and clinical data management, clinical data monitoring, regulatory affairs, or quality assurance. Physical Demands / Work Environment Office environment. Available for travel 5% of the time including overnight stays as necessary consistent with project needs and office location. Learn more about our EEO & Accommodations request here. Seniority Level Entry level Employment Type Full‑time Job Function Other #J-18808-Ljbffr