Assistant Director, Safety Operations (Pharmacovigilance)

Location: Not specified for this role. The company is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland.

Salary: $132,140–$170,189 annually.

Company

Ionis is a biotechnology company developing RNA-targeted medicines and gene-editing approaches for serious diseases, with a pipeline spanning neurology, cardiology, and other high-need areas.

What you will do

• Lead day-to-day patient safety operations across clinical development and post-marketing programs.
• Manage case-processing workflows, timelines, quality assurance, safety data exchanges, and submission responsibilities.
• Oversee safety vendors, business partners, service-level agreements, KPIs, and contract-related operational requirements.
• Identify and manage third-party quality events and CAPAs while driving process improvements.
• Maintain study blinding and perform unblinding where applicable according to SOPs.
• Support SOP development, regulatory inspections, audits, product launches, and cross-functional safety initiatives.

Requirements

• At least 10 years of experience in drug safety and pharmacovigilance.
• Degree in life sciences or equivalent experience, such as healthcare professional experience; an MD is not required.
• Excellent verbal and written English proficiency.
• Experience with Argus is required; experience with Veeva, eTMF, and EDC is preferred.
• Strong understanding of global pharmacovigilance regulations and safety reporting requirements, including ICH, FDA, EMA, and MHRA standards.
• Experience with complex operational projects, inspections, audits, vendor management, and commonly used Microsoft applications.

Nice to have

• Prior involvement in regulatory inspections or audits, including back-room or front-room support.
• Experience with Veeva, eTMF, and EDC.
• Experience developing pharmacovigilance agreements and negotiating contract terms.

Culture & Benefits

• Benefits package is offered.
• Work environments may be onsite, hybrid, or remote across the company, but no specific format is stated for this role.
• Patient safety, scientific excellence, innovation, and cross-functional collaboration are emphasized.
• Opportunities include mentoring, participation in global safety programs, and collaboration with clinical, regulatory, quality, and IT functions.