Drug Safety Associate III

Exelixis; Alameda (CA); On-site; USD 131,000 - 185,000; Full time

Benefits offered by this job

401k plan

Medical/Dental/Vision

Life & Disability Insurance

FSAs

Annual bonus program

Stock purchase plan

Long-term incentives

Vacation accrual

Job summary

Exelixis in the United States is seeking a Drug Safety expert responsible for managing SAEs and ensuring high-quality safety documentation in the Argus system. You will lead case processing, MedDRA coding, QA reviews, and coordination with Clinical Development, Regulatory Affairs, and Data Management, with oversight of study operations from start-up to close-out.

The role also includes training staff, scheduling submissions, and contributing to safety study plans, with a comprehensive benefits

Qualifications

• BS/BA or higher in clinical field with minimum 7 years related experience.
• MS/MA in clinical field with minimum 5 years related experience.
• PhD in clinical field with 0+ years related experience.
• Equivalent combination of education and experience.

Responsibilities

• Process and assess SAEs from receipt to case closure in Argus.
• MedDRA coding of SAEs and AEs; develop coding conventions.
• Ensure high standard of case quality review with safety physician support.
• Schedule expedited safety report submissions in ARGUS.
• Train new safety staff on Argus and case processing.
• Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management.
• Perform SAE reconciliation as required by safety management plan.

Skills

Biotech/pharma

Oncology experience

Argus knowledge

SAE processing

Regulatory knowledge

Analytical skills

Time management

Team collaboration

Mentoring

Education

BS/BA in clinical field

MS/MA in clinical field

PhD in clinical field

Equivalent education/experience

Certification in assigned area

Tools

Argus database

Job description

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 AND RESPONSIBILITIES:

Technical duties include but are not limited to:

• 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.
• 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.

The base pay range for this positionis $130,500 - $185,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. 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.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [e-mail].

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.