Executive Director, Head of Global Pharmacovigilance Operations, Quality & Compliance

<div class="content-intro"><div><strong>Why Join Us?</strong></div>

<div> </div>

<div><em>Be a hero for our rare disease patients</em></div>

<div><em> </em></div>

<div>At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. </div>

<div> </div>

<div>Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.</div>

<div> </div>

<div>If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team<em>. </em></div></div><h3 style="text-align: left;"><strong>Position Summary:</strong></h3>

<p style="text-align: left;"><em><strong>ultra</strong>dedicated – Your biggest challenges yield rare possibilities</em></p>

<p style="text-align: left;"><span class="TextRun SCXW201671997 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW201671997 BCX0">The Executive Director, Global Pharmacovigilance Operations, Quality & Compliance is accountable for the strategic leadership, operational effectiveness, and inspection-ready performance of Ultragenyx's global Pharmacovigilance (PV) Operations, Quality & Compliance function. This role oversees global case processing for investigational and marketed products, PV vendor oversight and governance, Alliance Management, Pharmacovigilance System Master File (PSMF) oversight, PV quality/compliance systems, training, deviation and Corrective and Preventive Action (CAPA) management, audit and inspection preparedness, and operational Trial Master File (TMF) support. The role </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW201671997 BCX0">ensures</span><span class="NormalTextRun SCXW201671997 BCX0"> the global PV system is scalable, compliant, and prepared to support portfolio growth, product approvals, commercialization, regional expansion, and successful regulatory inspections.</span></span><span class="EOP Selected SCXW201671997 BCX0" data-ccp-props="{"201341983":0,"335559739":160,"335559740":252}"> </span></p>

<h3 style="text-align: left;"><strong>Work Model: </strong></h3>

<p style="text-align: left;">Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.</p>

<h3 style="text-align: left;"><strong>Responsibilities:</strong></h3>

<p><strong><span data-contrast="none"><span data-ccp-parastyle="heading 2">Functional Leadership & Strategy</span></span></strong><span data-ccp-props="{"134245418":true,"134245529":true,"335559738":120,"335559739":40}"> </span></p>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"singleLevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Build, lead, coach, and mentor the Global Pharmacovigilance Operations, Quality & Compliance function and contribute to the Global DSPV talent strategy aligned with company long-range growth plans.</span></span><span data-ccp-props="{"335559739":40}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"singleLevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Establish functional </span><span data-ccp-parastyle="List Bullet">objectives</span><span data-ccp-parastyle="List Bullet">, operating model priorities, and long-range goals aligned with Corporate and Global DSPV objectives.</span></span><span data-ccp-props="{"335559739":40}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"singleLevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Ensure</span><span data-ccp-parastyle="List Bullet"> the global PV system is scalable, compliant, inspection-ready, and positioned to support portfolio growth, product approvals, commercialization, launches, and regional expansion.</span></span><span data-ccp-props="{"335559739":40}"> </span></li>

</ul>

<p><strong><span data-contrast="none"><span data-ccp-parastyle="heading 2">PV Operations</span></span></strong><span data-ccp-props="{"134245418":true,"134245529":true,"335559738":120,"335559739":40}"> </span></p>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"singleLevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Lead global PV operations, including intake, triage, case processing, quality control, regulatory reporting/submission, reconciliation, and oversight of safety information from all applicable products and sources.</span></span><span data-ccp-props="{"335559739":40}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"singleLevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Ensure PV operational activities </span><span data-ccp-parastyle="List Bullet">comply with</span><span data-ccp-parastyle="List Bullet"> applicable global regulatory requirements, Good Pharmacovigilance Practices (GVP), and Ultragenyx internal policies and procedures.</span></span><span data-ccp-props="{"335559739":40}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"singleLevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Oversee PV operational performance, vendor execution, trend monitoring, and continuous improvement to </span><span data-ccp-parastyle="List Bullet">maintain</span><span data-ccp-parastyle="List Bullet"> inspection-ready execution.</span></span><span data-ccp-props="{"335559739":40}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"singleLevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Provide operational support for all programs and oversight </span><span data-ccp-parastyle="List Bullet">for</span><span data-ccp-parastyle="List Bullet"> PV-related TMF activities, as applicable.</span></span><span data-ccp-props="{"335559739":40}"> </span></li>

</ul>

<p><strong><span data-contrast="none"><span data-ccp-parastyle="heading 2">PV Quality & Compliance</span></span></strong><span data-ccp-props="{"134245418":true,"134245529":true,"335559738":120,"335559739":40}"> </span></p>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"singleLevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Ensure maintenance of the Ultragenyx PV system, including PV policies, SOPs, procedures, forms, and process governance in alignment with global regulatory requirements, GVP, and industry best practices.</span></span><span data-ccp-props="{"335559739":40}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"singleLevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Own oversight and management of the Ultragenyx PSMF, ensuring on-demand readiness and compliance with applicable regulatory requirements.</span></span><span data-ccp-props="{"335559739":40}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"singleLevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="List Bullet">Establish and </span><span data-ccp-parastyle="List Bullet">maintain</span><span data-ccp-parastyle="List Bullet"> the global AE reporting training program and oversee training compliance with applicable Ultragenyx policies and procedures.</span></span><span data-ccp-props="{"335559739":40}"> </span></li>

</ul>

<ul>