[Hiring] Assistant/Associate Director, Pharmacovigilance Quality Assurance @Ionis Pharmaceuticals, Inc.

Role Description

We are seeking a highly motivated individual to join as an Assistant/Associate Director, Pharmacovigilance Quality Assurance. This is a hands-on QA role within Development Quality Assurance that supports the execution of a risk-based GVP quality program. This role partners closely with:

• Patient Safety and Pharmacovigilance
• Clinical Operations
• Clinical Development
• Regulatory Affairs
• Medical Affairs
• GMP QA
• Business partners and service providers

Core responsibilities include:

• Support implementation and maintenance of a comprehensive, risk-based GVP-compliant quality program covering clinical trial safety and post-marketed safety processes.
• Plan, conduct, and/or support end-to-end GVP audits of service providers, business partners, affiliates, and internal PV processes.
• Prepare and/or review timely, well-written audit reports and communicate findings to auditees, cross-functional representatives, and management.
• Assess and review audit responses to ensure CAPA plans adequately address findings and root causes.
• Develop, review, and/or revise audit plans, SOPs, guidance documents, templates, and related documents supporting PV QA activities.
• Support PV inspection readiness activities and participate in regulatory authority inspections.
• Provide PV QA guidance and training to internal stakeholders involved in clinical development and patient safety.
• Monitor relevant GVP regulatory intelligence and support assessment and implementation of new or revised requirements.
• Provide quality support to various functions on PV and clinical trial safety quality matters.
• Provide QA oversight support for PV and PV-related service providers across their lifecycle.
• Support development, maintenance, and communication of PV QA metrics and dashboards.
• Mentor, support, and/or manage the activities of internal and external Development QA personnel.
• Maintain effective organization, documentation, and communication practices.
• Use approved company technology to support responsibilities efficiently.

Qualifications

• For the Assistant Director role:
  • Bachelor’s degree with a minimum of 8 years
  • Master’s degree with a minimum of 6 years
  • PhD with a minimum of 3 years
• For the Associate Director role:
  • Bachelor’s degree with a minimum of 12 years
  • Master’s degree with a minimum of 8 years
  • PhD with a minimum of 5 years
• GVP quality assurance or relevant clinical trial safety experience within the pharmaceutical and biotechnology industry and/or service provider work experience is required.
• A healthcare/scientific-related discipline is highly desirable.

Requirements

• Strong GVP auditing and clinical safety experience required, including internal process, business partner, and service provider audits.
• Working knowledge of international GVP regulations, FDA and EMA pharmacovigilance and clinical trial safety requirements.
• Experience supporting or participating in global regulatory inspections, partner audits, and inspection-readiness activities.
• Good understanding of the clinical development process, risk-based quality systems approaches, clinical PV and post-market PV activities.
• Experience writing, reviewing, and revising SOPs and other controlled documents supporting PV activities.
• Experience with PV-related service provider oversight, quality agreements, CAPAs, deviations, and change controls preferred.
• Knowledge of computer system validation and data integrity concepts relevant to GVP/GCP systems is preferred.
• Strong interpersonal, verbal, and written communication skills.
• Strong organizational and time management skills.
• Ability to travel as business needs require, including on short notice when needed.

Benefits

• Ionis offers an excellent benefits package.
• Highly competitive benefits.

Company Description

Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.

We pride ourselves on cultivating a challenging, motivating, and rewarding environment that fosters innovation and scientific excellence.

We’re building on our rich history, and we believe our greatest achievements are ahead of us.