Ionis Pharmaceuticals, Inc. · 11 hours ago
Associate Director/Director, Patient Safety Operations
Carlsbad, CA
Full-time
Hybrid
Lead/Staff, Director/Executive
$187K/yr - $251K/yr
12+ years expIonis Pharmaceuticals, Inc. is a leader in RNA-targeted medicines and is seeking an Associate Director/Director of Patient Safety Operations. This role oversees Patient Safety Operations, ensuring compliance with regulatory requirements while managing end-to-end processes in drug safety operations.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
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
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
Preferred
Veeva, eTMF, and EDC experience preferred
Prior involvement in inspections or audits strongly preferred
Benefits
Ionis offers an excellent benefits package!
Company
Ionis Pharmaceuticals, Inc.
For three decades, Ionis has invented medicines that bring better futures to people with serious diseases.
501-1000 employees
H1B Sponsorship
Ionis Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (5)
2023 (3)
2022 (5)
2021 (5)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$2.45B2025-11-13Post Ipo Debt· $700M
2024-09-09Post Ipo Equity· $500.3M
2023-06-06Post Ipo Debt· $500M
Leadership Team
Brett P. Monia
Chief Executive Officer
Eric Bastings
Senior Vice President, Development Strategy
Recent News
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