Senior Product Complaint Operations Specialist (Pharmacovigilance)

Location: Durham, NC, United States; hybrid schedule with 4 days in the office and 1 day per week from home

Company

Develops pharmaceutical therapies for rare diseases and technologies designed to expand the availability of transplantable organs.

What you will do

• Manage day-to-day quality and compliance activities for end-to-end product complaint handling across devices, drugs, combination products, and biologics.
• Maintain complaint-handling procedures and systems for product complaints, MDRs, malfunction reports, FARs, BPDRs, returned goods, and investigations.
• Develop and deliver training on complaint handling, regulatory requirements, product risks, and user issues.
• Support vendor workflows, complaint investigations, returned goods authorizations, and timely complaint closure with QA teams.
• Coordinate with patients, pharmacists, physicians, specialty pharmacies, vendors, and internal stakeholders to obtain investigation information.
• Support inspections and audits, root cause analysis, CAPAs, deviation reviews, and escalation of complex regulatory and safety risks.

Requirements

• Bachelor’s degree in a relevant discipline, with 5+ years of pharmacovigilance case processing or product complaint management experience; alternatively, 3+ years with a master’s degree.
• At least 3 years of device and/or combination product experience and 2 years of product development and/or post-marketing drug experience.
• Strong knowledge of global regulations, guidelines, and best practices for complaint handling and end-to-end case management.
• Working knowledge of MedDRA coding, drug development processes, regulatory frameworks, and safety databases such as Argus.
• Strong analytical, communication, project management, organizational, and cross-functional collaboration skills.
• Ability to work independently in ambiguous situations, improve existing processes, and escalate high-risk compliance matters.

Nice to have

• Master’s degree in a relevant discipline.
• Additional product development and/or post-marketing drug experience.

Culture & Benefits

• Mission-driven work supporting patient safety, product quality, and therapies for unmet medical needs.
• Medical, dental, vision, and prescription coverage.
• Wellness resources, 401(k), and ESPP savings plans.
• Paid time off, paid parental leave, and disability benefits.
• Work environment emphasizing enthusiasm, creativity, persistence, and unconventional problem-solving.