Exelixis · 8 hours ago
Drug Safety Associate III
Alameda, CA
Full-time
Onsite
Senior Level
$124K/yr - $177K/yr
5+ years expExelixis is a biotechnology company focused on developing innovative therapies for cancer. The Drug Safety Associate III role is responsible for providing Drug Safety expertise, ensuring quality documentation of safety data, and managing case processing activities in compliance with regulations. This position also involves collaboration with various departments and oversight of drug safety study operational activities.
BiotechnologyHealth CarePharmaceutical
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
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
Qualification
Required
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
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
Preferred
Experience in Biotech/Pharmaceutical industry and/or in oncology preferred
Experience using Argus safety database preferred
Benefits
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
Opportunity to purchase company stock
Receive 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
Company
Exelixis
Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.
1001-5000 employees
H1B Sponsorship
Exelixis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (39)
2024 (25)
2023 (25)
2022 (28)
2021 (29)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Deerfield
2015-07-23Post Ipo Equity· $135M
2012-02-16Post Ipo Equity· $65M
2010-06-03Post Ipo Debt· $160M
Leadership Team
Michael Morrissey
President and CEO
Christopher Senner
Executive Vice President and CFO
Recent News
2026-01-12
The Motley Fool
2026-01-09
Company data provided by crunchbase