Drug Safety Associate II - Study Ops

Essential Duties/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 reviews to ensure sound medical safety data documentation with the support of the Drug Safety Physician.
• 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 plans 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).
• Performs SAE reconciliation, as required by safety management plan.
• Performs other duties as assigned.

Required Knowledge, Skills and Abilities

• Knowledge of biotechnology/pharmaceutical sector.
• Knowledge of regulatory framework governing patient safety.
• Adopts an analytical approach to solve problems relevant to the role.
• Demonstrates an understanding of organizational and planning capabilities by managing own time and resources to complete assigned work.
• Leads self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals.
• Provides verbal and written communications that are clear and easy to understand.
• Keeps management informed of potential issues in a timely manner.
• Works collaboratively with team members.
• Good interpersonal skills, understanding of differing views and participation in developing agreed upon resolutions.
• Trains on procedures, tasks and tools for role, supported by ongoing coaching and/or mentoring by departmental peers.
• Develops and maintains knowledge of cross-functional products, tools and data sources.

Compensation

The base pay range for this position is $116,500 - $165,500 annually. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.