Assistant Director/ Associate Director/ Director, Patient Safety Operations

Assistant Director/ Associate Director/ Director, Patient Safety Operations

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

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.

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)

Competencies identified for success:

Patient-Centricity:

Keeps patient safety and unmet medical needs at the core of all decisions.

Strategic & Operational Thinking:

Ability to align safety operations with broader development and regulatory strategy.

Anticipates operational needs and proactively addresses potential risks while maintaining long term department and company vision.

Leadership & Influence:

Demonstrates strong leadership in managing vendors, cross-functional teams, and safety projects.

Fosters collaboration across functions such as Clinical, Regulatory, Quality, IT, etc.

Coaches and mentors team members.

Pharmacovigilance Expertise:

Deep understanding of global PV regulations, case processing, aggregate reporting, and safety database management.

Proficient in evaluating operational impacts of new safety-related regulations and guidance.

Project & Vendor Management:

Manages multiple safety programs and vendors simultaneously with efficiency and accountability.

Contract experience: Familiarity with legal contracts, terms and conditions, and negotiation strategies.

Ensures delivery against service level agreements, KPIs, and regulatory timelines.

Quality & Compliance Orientation:

Demonstrates ownership of documentation, data integrity, and regulatory correspondence.

Identifies and implements continuous improvement opportunities within PV processes.

Collaboration & Communication:

Skilled in translating complex regulatory or safety requirements into practical operational guidance.

Data-Driven Decision Making:

Understands the role of safety data in clinical development and benefit-risk assessment.

Brings analytical rigor to operational oversight.

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; 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.