Workflow Manager, Pharmacovigilance Operations – Specialist II

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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 the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited from a clinical trial including safety database entry, AE review, write patient narratives with coding, follow-up of missing information, lists assessment against appropriate label (For Marketed products, if applicable). • Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners and Fortrea project personnel, if required & as agreed with client during study set-up, within study specified timelines. • Ensure all cases that require expediting reporting to worldwide Regulatory Agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines. • Work with Data Management or client on reconciliation of safety databases, if appropriate. • Support audit or inspection preparations. • Any 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 • 2 years of pharmacovigilance (PV) work experience in US/Canada • 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 the reporting of adverse events for both marketed and investigational products.

🏖️ Benefits

• Medical • Dental • Vision • Life • STD/LTD • 401(K) • Flexible time off (FTO)