Drug Safety Associate II - Study Ops

SUMMARY / JOB PURPOSE This role is responsible for providing Drug Safety expertise and ensuring the quality documentation of safety data, particularly serious adverse events (SAEs). The role supports all major tasks and oversees outsourced vendors related to case processing activities in the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations and Global Patient Safety department procedures in all aspects of drug safety case processing and reporting. The role also supports and oversees all aspects of drug safety study operational activities from study start‑up to close‑out. ESSENTIAL DUTIES / RESPONSIBILITIES Process and assess SAEs from receipt at Exelixis to case closure in the Argus database, including query generation, narrative and ASE writing. MedDRA code SAEs and AEs reported in source documents and develop/revise Exelixis MedDRA Coding Conventions. Define and apply a high standard of case quality reviews in collaboration with the Drug Safety Physician. Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management to ensure appropriate collection and handling of safety data. Perform Safety Study Lead activities, including review of Investigator Brochures, study protocols and participation on IND Annual Reports. Develop study‑specific safety management plans from Exelixis Drug Safety templates, review and update drug safety forms and templates, and harmonize with relevant clinical operation forms and templates. Perform SAE reconciliation as required by the safety management plan. Perform other duties as assigned and comply with all policies and standards. EDUCATION / EXPERIENCE / KNOWLEDGE / SKILLS & ABILITIES BS/BA in Nursing, Pharmacy, or related discipline and a minimum of 5 years of related experience; or MS/MA in Nursing, Pharmacy, or related discipline and a minimum of 3 years of related experience; or PhD in Nursing, Pharmacy, or related discipline and 0 or more years of related experience; or an equivalent combination of education and experience. Certification in the assigned area may be required. Experience in Biotech/Pharmaceutical industry and/or oncology preferred. Experience using Argus safety database preferred. Clinical trial and spontaneous adverse event processing experience. Knowledge of the biotechnology/pharmaceutical sector and the regulatory framework governing patient safety. Analytical problem‑solving ability, strong organizational and planning capabilities, effective verbal and written communication, and collaborative teamwork. Ability to manage own time and resources, deliver results, and keep management informed of potential issues. COMPENSATION & BENEFITS Base pay range: $116,500 – $165,500 annually, with adjustments for geographic region, job knowledge, skills, experience, and internal equity. Exelixis offers a comprehensive benefits package including 401(k) plan with company contributions, group medical, dental, and vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus, and potential stock purchase and long‑term incentive plans. Additional benefits include 15 accrued vacation days in the first year, 17 paid holidays (including a company‑wide winter shutdown in December), and up to 10 sick days per calendar year. WORKING CONDITIONS The office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. All necessary equipment, including dual monitors and ergonomic chairs, is provided to ensure a comfortable workspace. SUPPORT FOR DISABILITY We offer accommodations for applicants and employees with disabilities throughout the application and recruitment process. If you have a disability and need an accommodation, please email View email address on click.appcast.io. EEO STATEMENT We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or basis of disability or any other federal, state, or local protected class. #J-18808-Ljbffr Exelixis Inc