Associate Director/Director, Patient Safety Operations

Ionis • Carlsbad, CA

2d • $186,666 - $251,068

About The Position

This position 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. Requires close cross-functional collaboration and a deep understanding of interdependent safety data flows as tasks can be assigned as independent projects. Ensures compliance with applicable regulatory requirements and internal procedures while supporting the overall strategy, quality, and efficiency of the Patient Safety and Pharmacovigilance function. This position manages and oversees the end-to-end processes for the following and is not limited to: case processing oversight and compliance, expedited reporting submission and compliance management, vendor / CRO / Business Partner compliance management, safety data exchange and pharmacovigilance agreements (SDEAs and PVAs respectively), aggregate reporting planning / Drug Safety Surveillance (DSS) support, safety database administration / SME, inspection readiness, etc.

Requirements

• Minimum 12 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; Veeva, eTMF, and EDC preferred.
• Prior involvement in inspections or audits strongly preferred (back or front room).
• Demonstrated ability to manage complex operational projects across global timelines.
• Strong understanding of global pharmacovigilance regulations (ICH, FDA, EMA, MHRA, etc.) and safety reporting requirements.

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 and monitor global SUSAR compliance metrics.
• Maintain Blind across all individual studies, conducting Unblinding where applicable as per SOP.
• Manage and maintain Master SUSAR Submission Tracker (unblinded) to ensure oversight and compliance of all required submissions.
• Support the development, implementation, and maintenance of SOPs, work instructions, and procedural documents related to safety operations.
• Collaborate with IT and external safety database providers to manage safety systems (e.g., Argus), ensuring data quality, configuration updates, and system validation activities.
• 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.
• Support ongoing management and periodic updating of pharmacovigilance agreements including revising existing agreements or establishing new ones and updating contact lists and appendices.
• Manage and maintain Business Partner Operations Tracker to ensure oversight and compliance of all SDEAs and PVAs.
• Other Patient Safety and Pharmacovigilance tasks as assigned and required.

Benefits

• Ionis offers an excellent benefits package!
• Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our employee spotlight-,Benefits,-Employees are rewarded

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees