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). 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/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)
  • Perform SAE reconciliation as required by safety management plan.
• Performs other duties as assigned
• Complies with all policies and standards

SUPERVISORY RESPONSIBILITIES

• None

EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES

Education

• BS/BA degree in Nursing Pharmacy other clinical or related discipline and a minimum of 5 years of related experience; or
• MS/MA degree in Nursing Pharmacy other clinical or related discipline and a minimum of 3 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

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

Knowledge Skills and Abilities

Required:

• 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.

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WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment including dual monitors and ergonomic chairs to ensure a comfortable workspace.

DISCLAIMER:
The preceding job description has been designed 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.

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 and basis of disability or any other federal state or local protected class.