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/stated timelines.
Responsibilities
* Manage receipt and processing of all adverse event reports reported spontaneously from any source or solicited from a clinical trial, including safety database entry, AE review, writing patient narratives with coding, follow‑up of missing information, and assessment against appropriate label (for marketed products, if applicable).
* Manage submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, third‑party vendors, partner and Labcorp project personnel, as required and as agreed during study set‑up, within study specified timelines.
* Ensure cases requiring expedited reporting to worldwide regulatory agencies or other recipients are prioritized for processing and submission within applicable timelines.
* Prepare timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of serious adverse events (SAEs), annual IND reports, European annual safety reports (ASRs), Development Safety Update Report (DSUR), periodic reports (PRs) line listings, and aggregate reports.
* Execute routine quality reviews of AE reports and aggregate reports for other group members, ensuring case processing and data quality meet global regulatory compliance needs, including audit support.
* Maintain a strong understanding of Labcorp’s safety database conventions or client‑specific database conventions, as appropriate.
* Participate in signal detection, trend and pattern recognition activities, as appropriate.
* Act as a lead contact for projects, including global projects, ensuring communication and process harmonization.
* Work with data management or client on reconciliation of safety databases, if appropriate.
* Monitor workflow for assigned studies/programs to ensure all deadlines are met.
* Prepare and deliver safety presentations, including serious adverse event reporting at investigator meetings, client capabilities meetings, and department overview to internal clients.
* Maintain comprehensive understanding of Labcorp PSS SOPs, work instructions, guidance documents and directives associated with safety management, reporting and pharmacovigilance.
* Participate or contribute to development of departmental work instructions and SOPs, as appropriate.
* Generate monthly status and other project‑specific reports ensuring quality and accuracy of metrics/data.
* Support/train less experienced safety staff in all aspects of case handling, adverse event reporting and other work, as needed, and contribute to training material development and updates.
* Contribute to preparation of safety management plans (SMPs), reconciliation plans and other safety‑specific plans under supervision.
* Make decisions regarding adverse event reporting within the guidelines of each specific project.
* Assist PSS management in identifying out of scope work.
* Participate in project team and client meetings and liaise with clients, where appropriate.
* Participate in client or regulatory audits and support preparation if needed.
* Support quality issue resolution and implementation of process improvement initiatives/activities.
* Assist in review of cumulative safety data for submission to drug safety monitoring boards (DSMBs), regulatory authorities or clients.
* Assist with set‑up and provision of data to safety committees/DSMBs and assist in coordination of endpoint committees, as required.
* Build and maintain good PSS relationships across functional units.
* Be available for travel up to 10% of the time, including overnight stays as necessary.
* All other duties as needed or assigned.
Qualifications (Minimum Requirements)
* Education & experience: Non‑degree + 4 years of safety experience or 5‑6 years of relevant experience; associate degree + 3 years of safety experience or 4‑5 years of relevant experience; BS/BA + 3 years safety experience or 3‑4 years of relevant experience; MS/MA + 2 years safety experience or 3 years of relevant experience; PharmD + 2 years safety experience or 3 years of relevant experience.
* Safety experience includes processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
* Relevant experience includes experience in pharmaceutical, biotechnology, or CRO industry in areas such as medical affairs, clinical data entry/management, clinical data monitoring, regulatory affairs, or quality assurance.
* Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience
* Good verbal, written, and presentation skills.
* Good communication; ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
* High degree of accuracy with attention to detail.
* Team player.
* Ability to present and share useful business information across departments and functions.
* Ability to anticipate and identify problems and take appropriate action to correct.
* Knowledge of medical and drug terminology.
* Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
* Knowledge of ICH guidelines.
* Desirable knowledge of medical device reporting.
* Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products.
* Good knowledge and understanding of industry and R&D processes and objectives.
* Ability to work independently with minimal supervision.
* Good keyboard skills; knowledge of MS Office and Windows beneficial.
Preferred Qualifications
* Office environment or remote work allowed.
EEO & Accommodations
Fortrea is an equal opportunity employer. Accommodations requests can be made through our accommodations process.
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