Drug Safety Associate II

Exelixis Inc; Alameda (CA); On-site; USD 105,000 - 148,000; Full time

Benefits offered by this job

401k plan

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock purchase plan

Long-term incentives

Vacation days

Paid holidays

Sick days

Job summary

Exelixis Inc. seeks a Drug Safety professional to provide expertise in safety case processing, ensuring documentation quality for SAEs and data submitted in Argus.

You will work with cross-functional teams and external vendors to maintain regulatory compliance and high data integrity across safety reporting. The role requires a BS/BA in a clinical field with 3–5+ years of related experience, preferably with Biotech/Pharma and Argus experience.

Qualifications

• BS/BA in Nursing, Pharmacy or related discipline with 5+ years of relevant experience; or an MS/MA with 3+ years; or a PhD with applicable experience.
• Regulatory knowledge in biotech/pharma and clinical safety is required.
• Experience with Argus safety database and SAE processing is preferred.

Responsibilities

• Process and assess SAEs from receipt to case closure in Argus with narratives and ASE writing.
• MedDRA coding of SAEs and AEs and development of coding conventions.
• Perform high-quality safety data documentation with medical oversight.
• Coordinate submission of expedited safety reports as needed.
• Collaborate across Clinical Development, Data Management, Regulatory Affairs, and others.

Skills

SAE processing

Argus safety database

MedDRA coding

Pharmacovigilance knowledge

Vendor oversight

Education

BS/BA in Nursing or Pharmacy or related

MS/MA in Nursing or related

PhD in Nursing/Pharmacy or related

Tools

Argus Safety

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 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.

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.
• Collaborating with other Exelixis departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data.
• 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 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 zero 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. Clinical trial and spontaneous adverse event processing experience. Experience using Argus safety database preferred.

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 and understanding of differing views. Trains on procedures, tasks and tools for role, supported by ongoing coaching and/or mentoring by departmental peers. Develops and maintains knowledge of products, tools and data sources relevant to the role.

JOB COMPLEXITY:

Capable of following predefined procedures for specific tasks. Capable of identifying task-related challenges and prioritizing activity accordingly. Seeks help if task-related challenges are identified and implements proposed solutions.

COMPENSATION & BENEFITS:

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $104,500 - $148,000 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:

• 401k plan with generous company contributions
• group medical, dental and vision coverage
• life and disability insurance
• flexible spending accounts
• discretionary annual bonus program
• sales-based incentive plan (for field sales staff)
• opportunity to purchase company stock
• long-term incentives
• 15 accrued vacation days in their first year
• 17 paid holidays including a company-wide winter shutdown in December
• up to 10 sick days throughout the calendar year

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.

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too.

ACCOMMODATIONS:

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