Workflow Manager Pharmacovigilance Operations, US Remote

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.

Summary of Responsibilities:

• Manage end-to-endmovement of safety casesthrough all case processingworkflow steps,responsible for ensuringtimely case progression,identifying and mitigatingworkflow delays, andcoordinating staffingcoverage to support
  compliance with allreporting 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.

Qualifications (Minimum Required):

• 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.

Experience (Minimum Required):

• 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 managementtools
• 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.

Work Environment:

• Work is performed in a remote based office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
• Regular and consistent attendance
• Varied hours may be required

Pay Range: USD $80,000-$105,000 / annually

Benefits:All job offers will bebased on a candidate's skills and prior relevant experience, applicabledegrees/certifications,as well as internal equity and market data.Regular,full-timeor part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Flexible time off (FTO).

Application Deadline: June 8, 2026

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