Specialist Fulfilment Associate - Client Dedicated, Onsite in Horsham, PA

Fortrea • Durham, NC

9d • Onsite

About The Position

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.

Requirements

• 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

Responsibilities

• 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.

What This Job Offers

• Career Level: Mid Level
• Education Level: Associate degree