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 supportcompliance with allreporting timelinesMonitor workload distribution across teams and ensure optimal resource utilizationTrack case processing timelines to ensure compliance with regulatory and partner reporting requirementsIdentify workflow bottlenecks and implement corrective actionsProvide workflow updates and performance metrics to leadershipParticipate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are providedPerform vendor and partner reconciliation activities as requiredParticipate in project team and client meetings, where appropriate and prepare for and / or participate in client or regulatory auditsLead initiatives to enhance efficiency, reduce turnaround times, and improve data qualityMonitor KPIs (e.G., case cycle time, compliance rates, backlog trends)Collaborate with QA teams to maintain high-quality case processing and documentation standardsSupport audit and inspection readiness activitiesMaintain a comprehensive understanding of applicable Standard Operating Procedures (SOP), Work Instructions (WI), guidance documents, directives associated with Safety management, reporting and pharmacovigilanceEnsure 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 experienceMS/MA + 4 to 5 years of safety experiencePharmD + 3 to 5 years safety experienceDegree 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 managementtoolsStrong organizational and project management skillsAnalytical mindset with problem-solving capabilitiesGood 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 wristsOccasional crouching, stooping, with frequent bending and twisting of upper body and neckAbility to access and use a variety of computer software developed both in-house and off-the-shelfLight to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbsRegular and consistent attendanceVaried 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 #LI-SE1 Learn more about our EEO & Accommodations request here.
