Drug Safety Specialist

Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site. In order to move forward, you will need to create an account. Your password must be eight characters long, contain at least one special character, one capital letter and a number. We look forward to discovering your talents. Drug Safety Specialist Welcome to an inspired career At Halozyme, we’re proud of what we do, and we continue to do more. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo and advancing our mission. Join us as a Drug Safety Specialist and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives. How you will make an impact The Drug Safety Specialist supports a number of post-marketing and/or clinical safety activities, including, but not limited to, the handling of cases received from collaborating partners and/or identified in articles/abstracts, ensuring the uniform and timely intake, processing, and submission to regulatory agencies of individual case safety reports, if applicable. They ensure compliance with global regulations and Halozyme standard operating procedures. They review clinical trial and post-marketing safety information; and assist in the preparation of periodic safety reports, and other documents, as needed. In this role, you’ll have the opportunity to: Ensure that clinical and/or post marketing adverse event reports are received, tracked, evaluated, processed/imported into the Argus safety database (including the authoring of narratives/queries/QC), and distributed in an efficient and timely manner and in compliance with regulations and Halozyme SOPs Perform E2B importing and monitoring in Argus safety database Review literature articles and abstracts to identify valid ICSRs Perform data entry of post-marketing and clinical ICSRs into the safety database Complete adverse event reconciliation for ICSRs received from partners Manage the drug safety mailbox To succeed in this role, you’ll need: Bachelor’s degree in a life science required with at least 2 years drug safety experience Excellent knowledge of FDA safety reporting requirements Experience with Argus Experience with SDLC validation Experience with the content of pharmacovigilance documents such as SOPs, guidelines, safety plans Excellent written, verbal communication, and interpersonal skills Critical thinking skills are required In return, we offer you: Hybrid work flexibility Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement A collaborative, innovative team that works as one to amplify your impact—on your career, the work you do and patients’ lives. Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information