Drug Safety Associate II - Study Ops

Drug Safety Associate II role providing Drug Safety expertise and ensuring quality documentation of safety data (SAEs) with oversight of outsourced vendors in Argus Safety. Responsibilities include processing SAEs from receipt to case closure, MedDRA coding of SAEs/AEs, developing/rewriting MedDRA coding conventions, ensuring high standard of case quality, collaborating with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management, performing Safety Study Lead activities such as review of Investigator Brochures and study protocols, developing safety management plans, updating safety forms/templates, SAE reconciliation, and contributing to safety data handling and reporting. Requires knowledge of pharmacovigilance regulations, ability to manage time/resources, clear verbal/written communication, and cross-functional collaboration. Compensation ranges include base pay $116,500 - $165,500 annually with total rewards program and benefits; location Alameda, CA, USA; remote work not indicated; no relocation assumed. Education and experience details as stated; no explicit H1B sponsorship mentioned.