Specialist Fulfilment Associate Client Dedicated, Onsite in Horsham, PA

The Specialist Fulfilment Associate will lead adverse event followup 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 duediligence 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 followup 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 nonconformance 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 knowledgesharing SOP updates and departmental initiatives. Work independently with minimal supervision managing multiple priorities while demonstrating strong criticalthinking 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 crossfunctional 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.