Associate Director/Director, Safety Conventions & Quality Standards

Summary

This position plays a critical lead role in establishing, maintaining, and continuously improving the quality and convention framework that underpins Patient Safety Operations at Ionis. The role is responsible for defining and enforcing case processing conventions, strategizing and executing quality control (QC) programs, trending and analyzing errors, and translating findings into training and procedural improvements.

Responsibilities

• Develop, maintain, and enforce case processing conventions across all PS&PV operational activities, ensuring consistency and regulatory alignment for both clinical and post-marketing programs.

• Strategize the overall QC framework for safety operations — defining scope, frequency, sampling methodology, and risk-based prioritization of QC checks across ICSR case processing and safety operational outputs.

• Conduct prospective and retrospective QC checks on ICSRs, ensuring adherence to conventions, regulatory requirements, and internal standards.

• Prepare and maintain quality metrics dashboards and reports; trend error types across case processing activities to identify systemic issues and root causes.

• Translate QC findings and error trends into actionable feedback for operational teams and drive measurable quality improvements through targeted interventions.

• Identify training needs across the safety operations function based on QC findings, error trend analysis, regulatory updates, and convention changes.

• Develop, deliver, and maintain a comprehensive training program for case processing conventions, quality standards, and procedural requirements; ensure training completeness and currency across all relevant staff.

• Modify and update conventions and procedural documents in response to regulatory changes, audit findings, QC trends, new guidance, or process improvements to ensure ongoing compliance and operational excellence.

• Own and maintain the full suite of safety operations procedural documents — SOPs, work instructions, job aids, and convention guides — ensuring alignment with current regulations and internal practices.

• Collaborate cross-functionally with Clinical, Regulatory Affairs, Quality Assurance, IT, and external vendors to ensure convention alignment and consistent application of quality standards.

• Identify and manage quality events and associated Corrective and Preventive Actions (CAPAs) related to convention deviations and quality failures; track through to closure.

• Support continuous improvement initiatives across the PS&PV function by leveraging quality data, benchmarking against industry best practices, and championing a quality-first culture.

• Participate in cross-functional initiatives and serve as the safety conventions and quality subject matter expert (SME) on project teams and internal working groups.

Competencies

• Patient-Centricity

• Quality & Compliance Orientation

• Strategic & Operational Thinking

• Pharmacovigilance Expertise

• Data-Driven Decision Making

• Leadership & Influence

• Collaboration & Communication

Requirements

• Minimum 12 years of working experience within drug safety and pharmacovigilance, with a strong focus on case processing quality, conventions, or standards.

• Degree in life sciences or equivalent experience (e.g., HCP); MD not required.

• Proven experience developing and delivering training programs within a PV or drug safety context.

• Strong understanding of global pharmacovigilance regulations (ICH E2B, FDA, EMA, MHRA, etc.) and their implications for case processing conventions.

• Excellent communication skills including proficiency in verbal and written English.

• Proficiency in all commonly used Microsoft applications.

• Argus experience required; Veeva, eTMF, and EDC experience preferred.

• Experience with CAPA management and quality event handling within a PV operations environment.

• Prior involvement in regulatory inspections or audits preferred, particularly in relation to quality documentation and conventions.

• Demonstrated ability to manage multiple priorities and projects with strong attention to detail and a quality-first mindset.