Director, Safety Conventions & Quality Standards

Director, Safety Conventions & Quality Standards

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, 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. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

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. The position ensures that the PS&PV function operates with consistency, regulatory compliance, and a culture of continuous quality improvement across clinical and post-marketing programs.

This role serves as the functional owner of safety conventions and quality standards, working closely with ICSR Operations, Safety Systems, Submissions, and cross-functional partners including Regulatory Affairs, Clinical Operations, and Quality Assurance to ensure alignment and consistent application of standards across all safety activities.

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.
• Other Patient Safety and Pharmacovigilance tasks as assigned and required.

Competencies Identified for Success:

• Patient-Centricity
  • Keeps patient safety and unmet medical needs at the core of all quality and convention decisions.
• Quality & Compliance Orientation
  • Demonstrates ownership of quality standards, documentation integrity, and convention compliance across all safety operational activities.
  • Identifies and implements continuous improvement opportunities with rigor and follow-through.
• Strategic & Operational Thinking
  • Ability to design and operationalize a comprehensive QC and conventions framework aligned with regulatory strategy and business needs.
  • Anticipates operational quality risks and proactively addresses them before they impact compliance or patient safety.
• Pharmacovigilance Expertise
  • Deep understanding of global PV regulations, ICSR case processing standards, and associated regulatory guidance (ICH E2B, FDA, EMA, MHRA, etc.).
  • Proficient in evaluating the impact of new or revised safety regulations on conventions and quality practices.
• Training & Development
  • Skilled in identifying skill gaps and designing practical, targeted training programs that drive measurable behavioral change.
  • Able to translate complex regulatory or technical requirements into accessible training materials for diverse audiences.
• Data-Driven Decision Making
  • Brings analytical rigor to quality oversight uses error trending, metrics, and root cause analysis to drive objective, evidence-based improvements.
• Leadership & Influence
  • Demonstrates strong influence in driving quality culture and convention adherence across functions and vendors without direct line authority.
  • Coaches and mentors team members and operational staff on quality standards and convention best practices.
• Collaboration & Communication
  • Skilled in translating complex regulatory or safety requirements into clear, practical conventions and procedural guidance.
  • Builds strong relationships across Clinical, Regulatory, Quality Assurance, IT, and external vendors to ensure alignment.

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.
• Demonstrated expertise in ICSR case processing conventions, quality control methodologies, and procedural document management.
• 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.