Job Overview
Location
2 Locations
Job Type
Full-time
Category
Product Management
Date Posted
June 6, 2026
Full Job Description
đź“‹ Description
- • Oversee end-to-end processing of pharmacovigilance safety cases, ensuring timely progression and adherence to global regulatory reporting timelines
- • Monitor and optimize workflow efficiency by identifying bottlenecks, mitigating delays, and coordinating staffing coverage to maintain compliance
- • Track case processing timelines and KPIs including case cycle time, compliance rates, and backlog trends to ensure operational performance meets targets
- • Ensure all pharmacovigilance activities comply with FDA, EMA, ICH E2E guidelines, and other global regulatory requirements for adverse event reporting
- • Maintain comprehensive knowledge of company Standard Operating Procedures (SOPs), Work Instructions (WIs), and safety management guidance documents
- • Collaborate with Quality Assurance teams to uphold high standards for case documentation and data integrity
- • Participate in client and regulatory audits, preparing documentation and supporting inspection readiness activities
- • Generate monthly status reports and project-specific metrics with accuracy and attention to data quality
- • Perform vendor and partner reconciliation activities to ensure alignment in case processing and reporting
- • Participate in project team and client meetings as required, contributing workflow insights and operational updates
- • Lead initiatives to enhance efficiency, reduce turnaround times, and improve data quality across pharmacovigilance operations
- • Monitor workload distribution across teams to ensure optimal resource utilization and balanced case assignments
- • Utilize safety databases (e.g., Argus), workflow tracking systems, and case management tools to manage and report on case processing
- • Ensure all pharmacovigilance workflows align with Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3 as outlined in the company’s Health and Safety Manual
- • Perform duties in a remote office environment with occasional domestic and international travel to site locations
- • Maintain regular and consistent attendance with flexibility for varied work hours as needed
- • Operate computer software (in-house and off-the-shelf) with proficiency and perform repetitive hand movements for extended periods
- • Lift and carry objects up to 15-20 lbs as required for equipment and travel
🎯 Requirements
- • BS/BA with 4–5 years of safety experience OR MS/MA with 4–5 years of safety experience OR PharmD with 3–5 years of safety experience
- • Minimum 2 years of pharmacovigilance (PV) work experience in the US or Canada
- • Advanced command of English (speaking, writing, reading)
- • Strong knowledge of safety databases (e.g., Argus), workflow tracking systems, and case management tools
- • Demonstrated understanding of ICH guidelines and global regulatory requirements for adverse event reporting
- • Strong organizational, project management, and analytical problem-solving skills
🏖️ Benefits
- • Medical, Dental, and Vision insurance
- • Life, Short-Term Disability (STD), and Long-Term Disability (LTD) coverage
- • 401(k) retirement plan
- • Flexible Time Off (FTO)
- • Annual salary range of $80,000–$105,000 based on experience and qualifications
- • Eligibility for benefits for full-time or part-time employees working 20+ hours per week
Skills & Technologies
About Fortrea Holdings Inc.
Fortrea is a global contract research organization spun out from LabCorp in 2023 to provide drug development services across Phases I-IV. It offers clinical trial management, patient access solutions, regulatory consulting, and commercialization support to biopharmaceutical, medical device, and diagnostic clients. The company operates in more than 90 countries with 19,000 employees, leveraging therapeutic expertise in oncology, rare diseases, neuroscience, and other complex areas to accelerate therapies from lab to market while prioritizing patient experience and data-driven insights.
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