Workflow Manager, Pharmacovigilance Operations – Specialist II

🕒 August 5

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

💵 $80k - $105k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

⚙️ Operations

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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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 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

🎯 Requirements

• 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

🏖️ Benefits

• 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