Workflow Manager, Pharmacovigilance Operations – Specialist II

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🕒 il y a 2 jours

🌐 États-Unis, Canada – Distant

🇺🇸 États-Unis – Télétravail 🇨🇦 Canada – Télétravail

💵 $80 000 - $105 000 / an

⏰ Temps Plein

🟢 Junior

🟡 Intermédiaire

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Fortrea

Site WebLinkedInTous les Emplois

10 000+ employés

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

Fortrea est une organisation de recherche clinique (CRO) avec plus de 30 ans d'expérience, dédiée à accélérer le développement de traitements révolutionnaires en fournissant des solutions cliniques complètes pour les entreprises de biopharmacie et MedTech. Ils offrent une gamme de services incluant la gestion des essais cliniques, les services de pharmacologie, et la stratégie réglementaire, tous conçus autour des besoins de leurs clients. La mission de Fortrea est de placer les patients au cœur de leur travail, visant à apporter des thérapies innovantes sur le marché plus rapidement grâce à des approches personnalisées et basées sur les données.

Description

• Manage receipt and processing of adverse event reports from spontaneous and clinical-trial sources • Enter cases into safety databases and perform adverse-event review • Write patient narratives with coding and follow up on missing information • Assess listings against the appropriate product label for marketed products, where applicable • Submit expedited Serious Adverse Event reports to clients, regulatory authorities, ethics committees, investigators, vendors, partners, and project personnel when required • Prioritize cases requiring expedited reporting and ensure submission within regulatory and study-specific timelines • Coordinate workflow activities across safety operations and monitor case progression and compliance metrics • Identify and resolve workflow delays and support efficient resource utilization • Reconcile safety databases with Data Management or clients when appropriate • Support audit and inspection preparations • Provide operational support to client project teams and standalone programs • Perform other duties assigned by management

🎯 Exigences

• Associate degree plus 2–3 years of safety experience, or 4 years of relevant experience • Alternatively: non-degree plus 2–3 years of safety experience or 5 years of relevant experience; BS/BA plus 2 years of safety experience or 3–4 years of relevant experience; MS/MA plus 2 years of safety experience or 2–3 years of relevant experience; PharmD plus 2 years of safety experience or 2–3 years of relevant experience • Minimum 2 years of pharmacovigilance work experience • Safety experience processing AE/SAE reports, generating narratives and queries, working within safety databases, and supporting regulatory submissions • Experience supporting U.S. and/or Canadian regulatory environments preferred • Advanced command of English, including speaking, writing, and reading • Strong knowledge of safety databases such as Argus, workflow tracking systems, and case management tools • Strong organizational and project management skills • Analytical and problem-solving capabilities • Understanding of ICH guidelines and global regulatory requirements for adverse-event reporting for marketed and investigational products • Bachelor’s degree in life sciences, pharmacy, or a related field preferred; equivalent education and relevant experience considered • Must be legally authorized to work in the country of residence: United States or Canada • Fortrea cannot provide current or future employment sponsorship • Ability to use in-house and commercial computer software • Regular and consistent attendance • Varied hours may be required • Ability to remain stationary for 6–8 hours per day • Ability to perform repetitive hand and finger movements • Ability to occasionally crouch and stoop, and frequently bend and twist the upper body and neck • Ability to lift and carry 15–20 pounds

🏖️ Avantages

• Salary based on candidate skills, prior relevant experience, applicable degrees/certifications, internal equity, and market data • Remote-based work environment • Occasional domestic and international travel • Opportunities to contribute to Fortrea’s mission of advancing life-saving therapies