MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
This is an individual contributor position responsible for the management of clinical trial adverse event reports. The incumbent in this role will receive, process, and follow-up on adverse event reports to support pharmacovigilance activities and ensure regulatory compliance. Tasks include but are not limited to: data entry; coding; assessment; narrative writing; generating queries; reconciliation with clinical databases, business partners and other vendors; and assisting in the preparation of aggregate reports.
Responsibilities and Job Duties
Additional Duties for Product Safety Specialist II
Education, Credentials & Experience
Product Safety Specialist I
Product Safety Specialist II
Knowledge, Skills and Abilities
Additional Requirements for Product Safety Specialist II
Experience with Argus Safety Database
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email email@example.com or call (301) 354-3566 and/or 711 for TTD/TTY service.
Equal Opportunity Employer/Veterans/Disabled
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