Drug Safety Associate III

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 the management and best utilization of 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 provides support and oversight of all aspects of drug safety study operational activities from study start‑up to close‑out. ESSENTIAL DUTIES AND RESPONSIBILITIES Process and assess SAEs from receipt at Exelixis to case closure in Argus, including query generation, narrative, and ASE writing. MedDRA coding of SAEs and AEs from source documents, and develop/revise Exelixis MedDRA Coding Conventions to ensure consistent data categorization. Define and apply a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician. Schedule submissions of expedited safety reports in Argus as needed. Train new safety staff on Argus and case processing. Collaborate with other Exelixis departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data. Perform Safety Study Lead activities including reviewing Investigator Brochures, study protocols, and participating in IND Annual Reports to support the Drug Safety Physician. Develop study‑specific safety management plans from the Exelixis Drug Safety template, 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. Additional duties and responsibilities as required. SUPERVISORY RESPONSIBILITIES None. EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS Education / Experience: BS/BA in Nursing, Pharmacy, or related discipline with a minimum of 7 years of experience; or MS/MA with a minimum of 5 years; or PhD with no minimum experience; or an equivalent combination. Preferred: Experience in biotech/pharma, oncology, and proficiency with the Argus safety database; clinical trial and spontaneous adverse event processing experience. Knowledge / Skills: Knowledge of the biotechnology/pharmaceutical sector and regulatory framework governing patient safety; analytical problem‑solving; strong organizational and planning capabilities; clear verbal and written communication; effective team collaboration; interpersonal skills; training and mentoring of junior staff. JOB COMPLEXITY Follow predefined procedures for specific tasks. Identify task‑related challenges and prioritize activities. Escalate issues with broader impact. Implement solutions to address task‑related challenges. WORKING CONDITIONS Primarily indoors, performing clerical work. Expenses for work location vary by geographic region. EMPLOYMENT BENEFITS Compensation range: $124,500–$177,000 annually, adjusted for geographic region. Total Rewards program: 401(k) plan with company contributions, group health, dental, vision, life and disability insurance, flexible spending accounts. Discretionary annual bonus program; sales‑based incentive plan for field sales staff. Stock purchase program and long‑term incentives. Vacation: 15 accrued days in the first year. Paid holidays: 17 days, including a company‑wide winter shutdown in December. Sick days: up to 10 days per calendar year. DISCLAIMER & EEO STATEMENT The preceding job description is intended to indicate the general nature and level of work performed by employees within this classification. It is not comprehensive. 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 disability or any other federal, state or local protected class. #J-18808-Ljbffr Exelixis Inc