Workflow Manager – Pharmacovigilance Operations

Fortrea

Workflow Manager overseeing pharmacovigilance operations ensuring timely case processing and compliance requirements. Collaborating with teams and maintaining high documentation standards in remote role at Fortrea.

Posted 6/17/2026full-timeRemote • 🇺🇸 United StatesJuniorMid-Level💰 $80,000 - $105,000 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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.
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.
Candidates must be authorized to work in the United States without the need for current or future visa sponsorship.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

pharmacovigilancecase processingworkflow managementdata quality improvementregulatory complianceKPI monitoringreport generationproblem-solvingresource utilizationsafety case management

Soft Skills

organizational skillsproject managementanalytical mindsetcommunication skillsleadershipcollaborationtime managementattention to detailadaptabilitycritical thinking