Associate II, Patient Safety Solutions

Job not on LinkedIn

🔥 22 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. • Triage of incoming cases to prioritize for daily workflow management. • Perform medical adjudication for event validity/seriousness/expectedness/listedness/causality using the WHO-UMC system in coordination with the medical review team. • Data 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 and determine listedness against appropriate label. • Identify clinically significant information missing from the reports and ensure its collection and follow-up. • Ensure all cases that requiring expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines. • Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. • Support root cause analysis and CAPA plan development & implementation for identified quality issues as needed. • Support and/or participate in audits and inspections including the preparation as needed. • Demonstrate role-specific Core Competencies and company values on a consistent basis. • Build and maintain good PSS relationships across functional units. • Undertake any other duties as needed.

🎯 Requirements

• Associate’s degree RN + 2 years of Safety experience • BS/BA + 1 years of Safety experience • MS/MA + 1 years of Safety experience • PharmD + 1 years of Safety experience • Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. • Minimum of two years of pharmacovigilance (PV) work experience in Canada / US • Advanced command of English language, including speaking, writing, and reading. • Proven expertise in processing U.S. post-approval cases is mandatory • Proficient with the Argus safety database. • Strong typing ability and familiarity with Microsoft Office Suite and Windows environment is advantageous. • Strong attention to detail with a high degree of accuracy. • Ability to work independently with minimal supervision. • Good understanding of ICH guidelines and global regulatory requirements for the reporting of adverse events for both marketed and investigational products.

🏖️ Benefits

• All job offers will be based on a candidate’s skills and prior relevant experience • Applicable degrees/certifications • Internal equity and market data