Associate Patient Support Program Safety & PV Oversight Director

Location: Fully onsite at the Morrisville, North Carolina office, United States

Company

hirify.global is a public benefit corporation developing pharmaceutical therapies for rare diseases and technologies that expand the availability of transplantable organs.

What you will do

• Provide strategic oversight of safety data exchanged between patient support programs and global pharmacovigilance.
• Maintain quality and compliance standards for adverse event reporting, documentation, and data exchange.
• Guide compliance with global pharmacovigilance regulations, guidelines, and industry best practices.
• Serve as the primary escalation contact for internal stakeholders and patient support programs.
• Develop and deliver training for adverse event, product complaint, and safety report collection and reporting.
• Oversee reconciliation, inspections, audits, root cause analysis, deviations, and CAPA activities.

Requirements

• Bachelor’s degree in healthcare or life sciences, with 12+ years of pharmacovigilance experience in end-to-end ICSR processing; alternative experience thresholds apply for master’s or PharmD qualifications.
• At least 5 years of call center management and oversight experience.
• Experience with safety databases, including Argus, and ICSR processing or pharmacovigilance call center management.
• Strong knowledge of GvP regulations and QMS documentation requirements.
• Strong Microsoft Office, spreadsheet, communication, stakeholder influence, and independent problem-solving skills.
• Ability to work fully onsite at the Morrisville, North Carolina office.

Nice to have

• Bachelor’s degree in nursing, master’s degree in healthcare or life sciences, or Doctor of Pharmacy.
• At least 3 years of product development or postmarketing drug experience.
• At least 2 years of functional leadership or people management experience.
• RN state licensure or compact state licensure.

Culture & Benefits

• Mission-driven environment focused on unmet medical needs and patient benefit.
• Medical, dental, vision, and prescription coverage.
• Wellness resources, 401(k), and employee stock purchase plan.
• Paid time off, paid parental leave, and disability benefits.
• Work environment described as bold, creative, persistent, and unconventional.