Workflow Manager Pharmacovigilance Operations, US Remote

Fortrea•Durham, CA

20h•$80,000 - $105,000•Remote

About The Position

The Workflow Manager Pharmacovigilance Operations is responsible for overseeing, optimizing, and ensuring the efficient execution of end-to-end case processing and safety workflows. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.

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.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
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.

Responsibilities

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.