The Specialist Fulfilment Associate will lead adverse event follow‑up activities for Participating Affiliate Pharma ICSRs with limited supervision, ensuring regulatory compliance and audit readiness. This role supports operational excellence through accurate execution, proactive issue resolution, and direct reporter outreach to obtain additional case information. May also support due‑diligence activities and enhancements within the Global Safety System.
This is a PRN/On-Call, client dedicated, onsite role based in Horsham, PA.
What You Will Do:
Manage ICSR follow‑up activities, including initiating and tracking reporter outreach to obtain additional case information. Ensure accurate handling, validation, and distribution of inbound communications and documentation while maintaining trackers to support data integrity, compliance, and audit readiness. Escalate issues as needed and support CAPA, non‑conformance, root cause analysis, and trend reporting to drive continuous process improvement.
Collaborate closely with internal teams and external partners (e.g., Global Safety, CROs, vendors) to support workload management and issue resolution. Serve as a resource for complex cases and provide guidance to junior team members.
Participate in training, knowledge‑sharing, SOP updates, and departmental initiatives. Work independently with minimal supervision, managing multiple priorities while demonstrating strong critical‑thinking, communication, flexibility, and attention to detail.
Your Experience:
Associate degree required
3+ years in data, records, reporting, or workflow management.
Experience with reporter outreach, case documentation, and safety system workflows.
Working knowledge of global safety regulations and support of audit/inspection readiness.
Experience with CAPA, trend analysis, and issue resolution.
Proficiency using safety databases or global safety systems.
Strong cross‑functional collaboration, communication, and organizational skills.
Ability to work independently, manage multiple priorities, and maintain high attention to detail.
Strong written and verbal communication skills
Understanding of global pharmacovigilance regulations
Work Environment:
Work is performed in an 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.
Learn more about our EEO & Accommodations request here.
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What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
