Assistant/Associate Director, Pharmacovigilance Quality Assurance
Ionis Pharmaceuticals, Inc.
August 06, 2026
Remote
United States
Operations
Assistant/Associate Director, Pharmacovigilance QA (remote US-based; 10–15% travel)
Core Responsibilities
- Support implementation/maintenance of a risk-based GVP quality program for clinical trial safety and post-marketed safety.
- Plan, conduct, and/or support end-to-end GVP audits (service providers, partners, affiliates, internal PV processes): preparation, execution, reporting, CAPA follow-up and closure.
- Prepare/review audit reports; communicate findings; assess CAPA adequacy (root cause and effectiveness checks where appropriate) and ensure CAPAs are tracked through completion.
- Develop/revise audit plans, SOPs, guidance, templates for PV QA.
- Support PV inspection readiness and participate in health authority inspections and partner audits.
- Assess inspection/audit reports and communicate risks/recommendations to leadership.
- Provide PV QA guidance/training for internal stakeholders; monitor GVP regulatory intelligence and implement new/revised requirements.
- Provide QA quality support across Patient Safety/PV, Clinical Development/Operations, Regulatory and Medical Affairs; support PASS-related activities.
- Provide QA input for PV deviations, CAPAs, change controls, investigations; oversee PV service providers lifecycle.
- Develop PV QA metrics/dashboards; mentor/manage Development QA; support cross-GxP QA; use approved AI/digital tools with human oversight.
Requirements
- Assistant Director: BS 8+ yrs OR MS 6+ yrs OR PhD 3+ yrs in GVP QA or clinical trial safety (incl. service provider experience preferred); healthcare/scientific discipline highly desirable.
- Associate Director: BS 12+ yrs OR MS 8+ yrs OR PhD 5+ yrs (same experience expectations).
- Strong GVP auditing and clinical safety experience (internal, business partner, service provider audits); GCP auditing preferred.
- Working knowledge of international GVP; FDA/EMA PV and clinical trial safety requirements; GCP; health authority guidance; ICH.
- Experience with global regulatory inspections/partner audits/inspection readiness.
- Ability to write/revise SOPs and controlled documents; strong communication and cross-functional influence; strong organization/time management; travel as needed.
- Preferred: PV service provider oversight, quality agreements, CAPAs/deviations/change controls; computer system validation and data integrity concepts.
Benefits/Pay
- Pay scale: $121,205 to $196,548 (Assistant Director: $121,205–$162,726; Associate Director: $138,908–$196,548).
Application
- Apply via http://www.ionis.com; reference requisition #IONIS004096.
Core Responsibilities
- Support implementation/maintenance of a risk-based GVP quality program for clinical trial safety and post-marketed safety.
- Plan, conduct, and/or support end-to-end GVP audits (service providers, partners, affiliates, internal PV processes): preparation, execution, reporting, CAPA follow-up and closure.
- Prepare/review audit reports; communicate findings; assess CAPA adequacy (root cause and effectiveness checks where appropriate) and ensure CAPAs are tracked through completion.
- Develop/revise audit plans, SOPs, guidance, templates for PV QA.
- Support PV inspection readiness and participate in health authority inspections and partner audits.
- Assess inspection/audit reports and communicate risks/recommendations to leadership.
- Provide PV QA guidance/training for internal stakeholders; monitor GVP regulatory intelligence and implement new/revised requirements.
- Provide QA quality support across Patient Safety/PV, Clinical Development/Operations, Regulatory and Medical Affairs; support PASS-related activities.
- Provide QA input for PV deviations, CAPAs, change controls, investigations; oversee PV service providers lifecycle.
- Develop PV QA metrics/dashboards; mentor/manage Development QA; support cross-GxP QA; use approved AI/digital tools with human oversight.
Requirements
- Assistant Director: BS 8+ yrs OR MS 6+ yrs OR PhD 3+ yrs in GVP QA or clinical trial safety (incl. service provider experience preferred); healthcare/scientific discipline highly desirable.
- Associate Director: BS 12+ yrs OR MS 8+ yrs OR PhD 5+ yrs (same experience expectations).
- Strong GVP auditing and clinical safety experience (internal, business partner, service provider audits); GCP auditing preferred.
- Working knowledge of international GVP; FDA/EMA PV and clinical trial safety requirements; GCP; health authority guidance; ICH.
- Experience with global regulatory inspections/partner audits/inspection readiness.
- Ability to write/revise SOPs and controlled documents; strong communication and cross-functional influence; strong organization/time management; travel as needed.
- Preferred: PV service provider oversight, quality agreements, CAPAs/deviations/change controls; computer system validation and data integrity concepts.
Benefits/Pay
- Pay scale: $121,205 to $196,548 (Assistant Director: $121,205–$162,726; Associate Director: $138,908–$196,548).
Application
- Apply via http://www.ionis.com; reference requisition #IONIS004096.