Drug Safety Associate III

Drug Safety Expert

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.

Essential duties and responsibilities include:

• 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 include:

• None

Education/Experience/Knowledge & Skills:

• 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 in Biotech/Pharmaceutical industry and/or in oncology preferred.
• Experience using Argus safety database preferred.
• Clinical trial and spontaneous adverse event processing experience.

• 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 resolution.
• 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. 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