Job Description

Overview 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). This role provides support for all major tasks and oversight of 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. This role provides support and oversight of all aspects of drug safety study operational activities from study start up to close out. Responsibilities Essential duties and responsibilities: Processing and assessing SAEs from receipt at Exelixis to case closure in the Argus database, including query generation, narrative, and ASE writing. MedDRA coding of SAEs and AEs as reported in source documents of SAE reports and development/revision of Exelixis MedDRA Coding Conventions to ensure consistent data categorization. Defining and applying a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician. Scheduling submissions of expedited safety reports in ARGUS as needed. Training of new safety staff on Argus and case processing. Collaborating with other Exelixis departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data. Performing Safety Study Lead activities including: Review of Investigator Brochures, study protocols and participation on IND Annual Reports in support of the Drug Safety Physician. Development of study specific safety management plan from Exelixis Drug Safety template Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and CRF) Perform SAE reconciliation, as required by safety management plan. Additional duties and responsibilities as required. Supervisory Responsibilities None Education/Experience/Knowledge & Skills Education/Experience BS/BA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 7 years of related experience; or, MS/MA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 5 years of related experience; or, PhD in Nursing, Pharmacy, other clinical, or related discipline and 0 or more years of related experience; or, Equivalent combination of education and experience. May require certification in assigned area. Experience/The Ideal for Successful Entry into Job Experience in Biotech/Pharmaceutical industry and/or in oncology preferred. Experience using Argus safety database preferred. Clinical trial and spontaneous adverse event processing experience. Knowledge/Skills Knowledge of biotechnology/pharmaceutical sector. Knowledge of regulatory framework governing patient safety. Analytical approach to solve problems relevant to the role. Organizational and planning capabilities to manage time and resources effectively. Self-management and delivery of own work to support departmental goals. Clear verbal and written communications; keep management informed of potential issues in a timely manner. Collaborative work with team members. Good interpersonal skills and ability to participate in resolving differing views. Trains on procedures, tasks and tools for the role, supported by coaching and mentoring; develops knowledge of cross-functional products, tools and data sources; may mentor junior team members. Job Complexity Capable of following predefined procedures for specific tasks. Capable of identifying task-related challenges and prioritizing activity accordingly. Identifies and escalates issues that may have a broader impact. Implements solutions to address any task-related challenges. Working Conditions Environment: primarily working indoors, performing clerical work. Note: This description does not specify all duties and requirements of the position. Compensation and Benefits The compensation for this position reflects the cost of labor across several U.S. geographic markets and may vary by location. The base pay range for this position is $124,500 - $177,000 annually. The base pay range may consider geographic region, job-related knowledge, skills, experience, and internal equity. In addition to base salary, Exelixis offers a comprehensive benefits package, including a 401k plan with company contributions, medical, dental and vision coverage, life and disability insurance, flexible spending accounts, and a discretionary annual bonus program or field sales incentive plan. The company also offers stock purchase opportunities, long-term incentives, vacation, holidays, and sick leave as part of Total Rewards. Disclaimer The preceding job description is intended to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, disability, or any other protected class. #J-18808-Ljbffr Exelixis

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