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 for cancer and inflammatory diseases using an AI-integrated discovery engine.

What you will do

• Lead pharmacovigilance operations for assigned products across clinical development and post-marketing.
• Oversee end-to-end Individual Case Safety Report management, including quality review, regulatory submissions, retrospective review, and case-processing metrics.
• Support SAE reconciliation, Reference Safety Information updates, aggregate safety reporting, and safety data outputs.
• Collaborate with Clinical Operations, Data Management, Regulatory Affairs, and Medical Safety on safety data flow and reporting timelines.
• Oversee outsourced pharmacovigilance activities, vendors, KPIs/KQIs, corrective actions, and safety data exchange agreements.
• Support audits and regulatory inspections while developing PV infrastructure, systems, SOPs, 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.
• Experience managing or overseeing PV vendors/CROs, budgets, and invoicing.
• 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 or an equivalent system, including case processing and reporting workflows.
• Experience with SAE reconciliation, RSI tracking, aggregate safety reporting, SOP documentation, audits, and inspections.

Nice to have

• PharmD, MS, or PhD.
• Experience supporting FDA, EMA, or other health authority inspections and audits.
• Experience across the full product lifecycle from clinical development through post-marketing.

Culture & Benefits

• Strongly collaborative, team-oriented environment.
• Solutions- and results-oriented approach.
• Hands-on, resourceful working style with openness to diverse points of view.