Associate II, Patient Safety Solutions

🔥 0 minutes ago

🇨🇦 Canada – Remote

💵 $67k - $82k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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

• Assist with overall Clinical Safety and/or Patient Safety Solutions operations • Manage receipt and processing of spontaneous and clinical-trial adverse event reports • Triage incoming cases and perform medical adjudication for event validity, seriousness, expectedness, listedness, and causality using the WHO-UMC system • Enter safety data into adverse event databases and tracking systems • Review adverse events for completeness, accuracy, and appropriateness for expedited reporting • Write patient narratives and code adverse events using MedDRA • Determine listedness against the appropriate label for marketed products • Identify missing clinically significant information and ensure collection and follow-up • Process cases requiring expedited reporting to worldwide regulatory agencies within required timelines • Maintain understanding of SOPs, Work Instructions, guidance documents, and directives • Support root cause analysis and CAPA plan development and implementation • Support or participate in audits and inspections • Build and maintain Patient Safety Solutions relationships across functional units • Undertake other duties as needed

🎯 Requirements

• Associate’s degree RN + 2 years of Safety experience, or BS/BA + 1 year of Safety experience, or MS/MA + 1 year of Safety experience, or PharmD + 1 year of Safety experience • Fortrea may consider relevant and equivalent experience in lieu of educational requirements • 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 reporting adverse events for marketed and investigational products • Willingness to work flexible or varied hours • Regular and consistent attendance • Ability to access and use various computer software • Ability to perform repetitive hand movements and remain stationary for 6–8 hours per day • Ability to lift and carry up to 15–20 lbs

🏖️ Benefits

• Full-time, home-based position • Flexible hours as needed to meet business needs • Occasional domestic and international travel