Pharmacovigilance Specialist

<p class=""p1"">Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.</p>

Aliso Viejo, CA


<h4>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</h4> <h4>Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.</h4>

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Full time

Overview: <p><strong>Pharmacovigilance Specialist</strong></p> <p>The Pharmacovigilance Specialist will report to the Senior Manager, Pharmacovigilance. This position will be remote. This individual is responsible for Post Market and Clinical trial PV Case Processing. This role requires an individual who can perform at a high level in a fast-paced environment and prior safety-related expertise, with an ability to understand and comply with general pharmaceutical industry rules, regulations, and company processes.</p> <p><strong>How will you make an impact?</strong></p> <p>The<strong>&nbsp;Pharmacovigilance Specialist</strong>&nbsp;will report to the Senior Manager, Pharmacovigilance. &nbsp;This role requires an individual who will be processing adverse event information for spontaneous, solicited literature and phase IV study cases. Perform Drug safety activities to ensure compliance with Pharmaceutical and Medical device regulations.</p>
Responsibilities: <ul><li>Perform tasks and duties in compliance with appropriate SOP, policies, and procedures.</li><li>Responsible for Global Pharmacovigilance review of ICSRs in safety database for completeness, accuracy and regulatory reportability.</li><li>Filing of safety related documents and ICSRs.</li><li>Review adverse event data from product complaints, inquiries, and literatures and assess for regulatory reporting requirements.</li><li>Identifies information to be queried and follows up with PV vendor/Medical safety until information is obtained and queries are satisfactorily resolved.</li><li>Collaborate with cross functional development functions</li><li>Medical, Clinical Operations, Data Management, Biostatistics, Regulatory, etc.</li><li>Assist Pharmacovigilance department in safety and risk management activities and other relevant safety projects or duties as assigned/needed.</li><li>Ensure that all safety reporting requirements of the FDA and other regulatory agencies are met.</li><li>Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary. </li></ul>
Requirements: <ul><li>Bachelor's Degree in a Life Sciences discipline required; Graduate degree and/or post-doctoral training preferred.</li><li>Minimum of 3 to 5 years of direct experience in a drug safety/pharmacovigilance environment within the pharmaceutical industry required.</li><li>Safety Database systems and knowledge of medical terminology required.</li><li>Good understanding of Post marketing safety requirements for device/combination products.</li><li>Knowledge of FDA, ICH and GCP regulations.</li><li>Proven ability to work with a high level of integrity, accuracy, and attention to detail.</li><li>Strong technical and analytical skills to identify and solve problems.</li><li>Good organizational skills with proven ability to prioritize projects. Excellent written and oral communication skills. </li></ul>