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-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.
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 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.
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 be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or 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#LI-SE1
