PV QA Assistant/Associate Director – Audits & Readiness

Ionis Brand; United States; Remote; USD 121,000 - 197,000; Full time

Job summary

Ionis Pharmaceuticals, Inc. seeks an Assistant/Associate Director, Pharmacovigilance Quality Assurance to lead and execute a risk-based PV QA program.

You will partner with Patient Safety, Clinical Operations, Regulatory Affairs, and GMP QA to support audits, inspections, CAPA follow-ups, and continuous improvement across PV systems. The role requires strong GVP auditing experience and the ability to mentor teams, while using approved AI-enabled tools in a compliant manner to ensure inspection

Qualifications

• GVP auditing and clinical safety experience required.
• Experience with internal and external PV audits and inspections.
• Knowledge of GVP, FDA/EMA pharmacovigilance requirements and ICH guidelines.

Responsibilities

• Support end-to-end GVP audits of service providers and internal PV processes.
• Assist with PV inspection readiness and regulatory inspections.
• Provide QA guidance to clinical development, patient safety, and other PV-related functions.

Skills

GVP auditing

Clinical safety

QA oversight

Cross-functional collaboration

Regulatory awareness

Education

Bachelor's degree in a healthcare/scientific field

Master's degree (preferred)

PhD in a related field (beneficial)

Tools

GVP/GCP data systems

SOP development tools

Job description

Ionis Pharmaceuticals, Inc. seeks an Assistant/Associate Director, Pharmacovigilance Quality Assurance to lead and execute a risk-based PV QA program.

You will partner with Patient Safety, Clinical Operations, Regulatory Affairs, and GMP QA to support audits, inspections, CAPA follow-ups, and continuous improvement across PV systems. The role requires strong GVP auditing experience and the ability to mentor teams, while using approved AI-enabled tools in a compliant manner to ensure inspection