Assistant Director/ Associate Director/ Director, Patient Safety Operations
Ionis Pharmaceuticals, Inc.
August 23, 2026
Remote friendly (Carlsbad, CA)
United States
Operations
Summary
Plays a key lead role overseeing Patient Safety Operations (clinical development and post marketing) and supporting global pharmacovigilance systems and processes. Ensures compliance with regulatory requirements and internal procedures while supporting the strategy, quality, and efficiency of Patient Safety and Pharmacovigilance.
Responsibilities
- Lead day-to-day drug safety operations tasks across clinical and post-marketing programs.
- Manage case processing workflows, timelines, and quality assurance with internal/external teams.
- Manage safety vendors to ensure compliance with agreements and KPIs.
- Identify/manage third-party quality events, CAPAs, and process improvements.
- Maintain study blind; conduct unblinding where applicable per SOP.
- Develop/implement/maintain SOPs, work instructions, and procedural documents for safety operations.
- Ensure readiness for regulatory inspections and audits; support inspection activities (pre/during/post).
- Serve as safety operations SME on cross-functional project teams.
- Support pharmacovigilance agreement (PVA) manager for compound safety operational documentation.
- Support safety/PV tasks for product launches; support business partners and vendor collaborations.
- Coordinate partner safety data exchange (case transfers, listings, submissions) aligned to partner requirements.
- Enhance PV inspection readiness; support internal/external audits; maintain audit/inspection-ready documentation.
Requirements
- 10+ years in drug safety and pharmacovigilance.
- Degree in life sciences or equivalent experience (MD not required).
- Excellent verbal and written English communication.
- Proficiency in Microsoft applications.
- Argus required; Veeva, eTMF, and EDC preferred.
- Prior inspection/audit involvement strongly preferred.
- Ability to manage complex operational projects across global timelines.
Application
Apply via Ionis website; reference requisition # IONIS003996.
Benefits/Pay
- Pay scale: $132,140–$268,875 (Assistant Director: $132,140–$170,189; Associate Director: $164,792–$221,777; Director: $202,235–$268,875).
Plays a key lead role overseeing Patient Safety Operations (clinical development and post marketing) and supporting global pharmacovigilance systems and processes. Ensures compliance with regulatory requirements and internal procedures while supporting the strategy, quality, and efficiency of Patient Safety and Pharmacovigilance.
Responsibilities
- Lead day-to-day drug safety operations tasks across clinical and post-marketing programs.
- Manage case processing workflows, timelines, and quality assurance with internal/external teams.
- Manage safety vendors to ensure compliance with agreements and KPIs.
- Identify/manage third-party quality events, CAPAs, and process improvements.
- Maintain study blind; conduct unblinding where applicable per SOP.
- Develop/implement/maintain SOPs, work instructions, and procedural documents for safety operations.
- Ensure readiness for regulatory inspections and audits; support inspection activities (pre/during/post).
- Serve as safety operations SME on cross-functional project teams.
- Support pharmacovigilance agreement (PVA) manager for compound safety operational documentation.
- Support safety/PV tasks for product launches; support business partners and vendor collaborations.
- Coordinate partner safety data exchange (case transfers, listings, submissions) aligned to partner requirements.
- Enhance PV inspection readiness; support internal/external audits; maintain audit/inspection-ready documentation.
Requirements
- 10+ years in drug safety and pharmacovigilance.
- Degree in life sciences or equivalent experience (MD not required).
- Excellent verbal and written English communication.
- Proficiency in Microsoft applications.
- Argus required; Veeva, eTMF, and EDC preferred.
- Prior inspection/audit involvement strongly preferred.
- Ability to manage complex operational projects across global timelines.
Application
Apply via Ionis website; reference requisition # IONIS003996.
Benefits/Pay
- Pay scale: $132,140–$268,875 (Assistant Director: $132,140–$170,189; Associate Director: $164,792–$221,777; Director: $202,235–$268,875).