Workflow Manager, Pharmacovigilance Operations – Specialist II

🕒 Agosto 5

🌐 Estados Unidos, Canadá – Remoto

🇺🇸 Estados Unidos – Remoto (EUA) 🇨🇦 Canadá – Remoto

💵 $80.000 - $105.000 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

⚙️ Operações

🚫👨‍🎓 Sem graduação necessária

👻 Score fantasma 10%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Fortrea

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

Fortrea é uma organização de pesquisa clínica (CRO) com mais de 30 anos de experiência, dedicada a acelerar o desenvolvimento de tratamentos que mudam vidas ao fornecer soluções clínicas abrangentes para empresas biofarmacêuticas e de MedTech. A empresa oferece uma gama de serviços, incluindo gestão de ensaios clínicos, serviços de farmacologia e estratégia regulatória, todos concebidos de acordo com as necessidades dos clientes. A missão da Fortrea é colocar os pacientes no centro do seu trabalho, buscando levar terapias inovadoras ao mercado mais rapidamente por meio de abordagens personalizadas e orientadas por dados.

Descrição

• Manage receipt and processing of adverse event reports from spontaneous sources and clinical trials • Enter cases into the safety database and conduct AE review • Write patient narratives with coding • Follow up on missing information • Assess listedness against the appropriate label for marketed products, where applicable • Submit expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and Fortrea project personnel as required • Prioritize cases requiring expedited reporting and ensure submission within regulatory and study-specific timelines • Work with Data Management or clients on safety database reconciliation • Support audit and inspection preparations • Coordinate workflow activities across safety operations • Monitor case progression and compliance metrics • Identify and resolve workflow delays • Ensure efficient resource utilization and high-quality service delivery • Provide operational support to client project teams and standalone programs • Perform other duties as assigned by management

🎯 Requisitos

• Non-degree + 2–3 years of Safety experience or 5 years of relevant experience • Associate degree + 2–3 years of Safety experience or 4 years of relevant experience • BS/BA + 2 years of safety experience or 3–4 years of relevant experience • MS/MA + 2 years of safety experience or 2–3 years of relevant experience • PharmD + 2 years of safety experience or 2–3 years relevant experience • Minimum of 2 years of pharmacovigilance (PV) work experience • Advanced command of English language, including speaking, writing, and reading • Strong knowledge of safety databases (e.g., Argus), workflow tracking systems, and case management tools • Strong organizational and project management skills • Analytical mindset with problem-solving capabilities • Good understanding of ICH guidelines and global regulatory requirements for reporting adverse events for marketed and investigational products • Experience supporting U.S. and/or Canadian regulatory environments is preferred • 4–5 years of experience in pharmacovigilance or drug safety operations is preferred • Bachelor’s degree in life sciences, pharmacy, or a related field is preferred; equivalent combination of education and relevant experience will also be considered • Must be legally authorized to work in the country in which they reside (United States or Canada) • Fortrea is unable to provide current or future employment sponsorship • Regular and consistent attendance • Ability to work varied hours as required • Ability to access and use in-house and off-the-shelf computer software • Ability to perform physical requirements including frequent stationary work, repetitive hand movements, occasional crouching/stooping, frequent bending/twisting, and lifting up to 15–20 lbs

🏖️ Benefícios

• Remote based office environment • Occasional travel, both domestic and international • Light to moderate lifting/carrying allowance for luggage and laptop computer up to 15–20 lbs • All job offers based on skills, prior relevant experience, applicable degrees/certifications, internal equity, and market data