Associate Clinical Safety Surveillance Director (Pharmacovigilance)

Location: Durham, North Carolina, United States; hybrid schedule with at least 3 days in the office each week

Company

hirify.global is a publicly traded biotech and pharmaceutical company developing therapies for rare diseases and technologies to expand the availability of transplantable organs.

What you will do

• Lead oversight of serious adverse events (SAEs) and adverse events of special interest (AESIs) across sponsored clinical trials.
• Provide strategic direction for clinical pharmacovigilance processes, vendors, systems, and operational metrics.
• Evaluate and implement process changes, SOPs, safety management plans, and procedural documents in response to regulatory and business needs.
• Ensure global compliance for safety data collection, ICSR case management, evaluation, quality control, and regulatory submissions.
• Lead inspection and audit readiness, root-cause analyses, deviations, and CAPA activities.
• Train and manage direct reports while collaborating with investigators, vendors, and cross-functional GPS stakeholders.

Requirements

• Bachelor’s degree with 12+ years, master’s degree with 10+ years, or PharmD/PhD/MD/DO with 7+ years of pharmacovigilance experience in end-to-end clinical trial ICSR processing.
• 5+ years of vendor management or clinical trial oversight and 5+ years of clinical trial or product development experience.
• 3+ years of functional leadership or people management experience, including prior clinical pharmacovigilance management.
• Experience with end-to-end case processing, safety databases such as Argus, regulatory submissions, and MedDRA coding.
• Knowledge of global GCP/GVP regulations, drug development, and safety requirements for devices, biologics, and drug products.
• Strong project management, analytical, communication, cross-functional collaboration, and problem-solving skills.

Culture & Benefits

• Mission-driven environment focused on unmet medical needs and rare, life-threatening diseases.
• Medical, dental, vision, and prescription coverage.
• Wellness resources, 401(k), and employee stock purchase plan.
• Paid time off, paid parental leave, and disability benefits.
• Hybrid work arrangement subject to changing business needs.