Director, Patient Safety Operations

Ionis•Carlsbad, CA

2d•Hybrid

About The Position

Ionis Pharmaceuticals, Inc. is seeking an Assistant Director/ Associate Director/ Director, Patient Safety Operations. This role plays a key lead role in overseeing the multidisciplinary arena of Patient Safety Operations (clinical development and post marketing), supporting the global pharmacovigilance systems and associated processes. It requires close cross-functional collaboration and a deep understanding of interdependent safety data flows, as tasks can be assigned as independent projects. The position ensures compliance with applicable regulatory requirements and internal procedures while supporting the overall strategy, quality, and efficiency of the Patient Safety and Pharmacovigilance function.

Requirements

At least 10 years of working experience within drug safety and pharmacovigilance.
Degree in life sciences or equivalent experience e.g. HCP; MD not required.
Excellent communication skills including proficiency in verbal and written English.
Proficiency in all commonly used Microsoft applications.
Argus experience required.
Demonstrated ability to manage complex operational projects across global timelines.

Nice To Haves

Veeva, eTMF, and EDC preferred.
Prior involvement in inspections or audits strongly preferred (back or front room).

Responsibilities

Lead and oversee day-to-day drug safety operations macro and micro tasks assigned across clinical and post-marketing programs.
Manage case processing workflows, timelines, and quality assurance in collaboration with internal and external teams.
Manage Safety vendors to ensure compliance with agreements and KPIs.
Identify and manage Third Party quality events, associated CAPAs, and further process improvements.
Maintain blind across all individual studies, conducting Unblinding where applicable as per SOP.
Support the development, implementation, and maintenance of SOPs, work instructions, and procedural documents related to safety operations.
Ensure readiness for regulatory inspections and audits; support inspection activities (pre, during, and post).
Participate in cross-functional initiatives and serve as the safety operations subject matter expert (SME) on project teams.
Support the pharmacovigilance agreements (PVA) manager in developing the overall agreement to ensure all Safety Operational aspects for that compound is documented and agreed to.
Other Patient Safety and Pharmacovigilance tasks as assigned and required associate with product launches.
Support growing business partners and vendor collaborations.
Coordinate business partner safety data exchange operations (case transfers, listings, submission responsibilities), ensuring alignment with partner requirements.
Enhance PV inspection readiness and support with audits (internal and external).
Maintain audit/inspection-ready documentation (example for PADE FDA Inspection, mock inspections etc).