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!

ASSISTANT DIRECTOR/ ASSOCIATE DIRECTOR/ DIRECTOR, PATIENT SAFETY OPERATIONS

SUMMARY: 

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.

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)

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