Workflow Manager, Pharmacovigilance Operations

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🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $80k - $105k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

⚙️ Operations

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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 end-to-end movement of safety cases through all case processing workflow steps, responsible for ensuring timely case progression, identifying and mitigating workflow delays, and coordinating staffing coverage to support compliance with all reporting timelines • Monitor workload distribution across teams and ensure optimal resource utilization • Track case processing timelines to ensure compliance with regulatory and partner reporting requirements • Identify workflow bottlenecks and implement corrective actions • Provide workflow updates and performance metrics to leadership • Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided • Perform vendor and partner reconciliation activities as required • Participate in project team and client meetings, where appropriate and prepare for and / or participate in client or regulatory audits • Lead initiatives to enhance efficiency, reduce turnaround times, and improve data quality • Monitor KPIs (e.g., case cycle time, compliance rates, backlog trends) • Collaborate with QA teams to maintain high-quality case processing and documentation standards • Support audit and inspection readiness activities • Maintain a comprehensive understanding of applicable Standard Operating Procedures (SOP), Work Instructions (WI), guidance documents, directives associated with Safety management, reporting and pharmacovigilance • Ensure all PV activities comply with global regulatory requirements (FDA, EMA, ICH E2E guidelines, etc.) • All other duties as needed or assigned.

🎯 Requirements

• BS/BA + 4 to 5 years of minimum safety experience • MS/MA + 4 to 5 years of safety experience • PharmD + 3 to 5 years safety experience • Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area. • Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. • Minimum of 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)