Associate Director, Pharmacovigilance Operations

Location: Onsite in Brisbane, California, United States

Salary: $229,500–$255,867 per year

Company

hirify.global is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines and small-molecule therapies for cancer and immune disorders, using an AI-integrated discovery engine and proprietary E3 ligase expertise.

What you will do

• Lead pharmacovigilance operations for assigned products across the clinical development and post-marketing lifecycle.
• Oversee end-to-end Individual Case Safety Report management, including quality review, regulatory submissions, retrospective review, and case-processing metrics.
• Coordinate SAE reconciliation, Reference Safety Information updates, safety data outputs, and aggregate safety reporting.
• Collaborate with Clinical Operations, Data Management, Regulatory Affairs, and Medical Safety on safety data flow and reporting timelines.
• Oversee outsourced PV activities and vendors, including KPIs, KQIs, contractual performance, corrective actions, and safety data exchange agreements.
• Support audits and regulatory inspections while developing PV infrastructure, systems, SOPs, work instructions, and process improvements.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field; an advanced degree is preferred.
• 8–10 years of pharmacovigilance or drug safety experience, including PV operations, ICSR management, and clinical safety support.
• Prior experience overseeing PV vendors or CROs, managing PV budgets and invoicing, and supporting audits or regulatory inspections.
• Working knowledge of global PV regulations and guidelines, including 21 CFR, EU GVP, ICH E2 series, and GVP Modules.
• Hands-on experience with global safety databases such as Argus Safety, SAE reconciliation, RSI tracking, and aggregate safety reporting.
• Strong vendor management, analytical, organizational, project management, communication, quality, and compliance skills.

Culture & Benefits

• Highly collaborative, team-oriented environment.
• Solutions- and results-oriented approach.
• Hands-on and resourceful working style with openness to diverse perspectives.
• Full-time onsite position in Brisbane, California.