New · posted Nov 1
Exelixis · Biotechnology
Drug Safety Associate II
- Alameda, CA
- On-site
- Full-time
- Associate & Specialist
The role
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.
What you need
Two ways to qualify
Bachelor’s
+ 5+ years of experience
BS/BA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 5 years of related experience ; or,
- or
Master’s
+ 3+ years of experience
MS/MA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 3 years of related experience; or,
Education/Experience
- 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.
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.
Experience/The Ideal for Successful Entry into Jobnice to have
- Experience in Biotech/Pharmaceutical industry and/or in oncology preferred.
- Clinical trial and spontaneous adverse event processing experience.
- Experience using Argus safety database preferred.
What you'll do
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.
- 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
Pay and benefits
$104,500 – $148,000 a year
Employer providedJOB 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.
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 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: [email protected].
401k with company contributions
Medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus
Employee stock purchase and long-term incentives
Where you'll work
Alameda, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Alameda, CAWorking 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.
Equal opportunity, accessibility and legal noticesExelixis's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 37% above the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $104,500 | — | $148,000 |
| All US (middle half) | $77,750 | $92,000 | $102,500 |
This role: Exelixis's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 162 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Exelixis's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs6
- Collaboration and leadership5
- Clinical trial conduct3
- GMP and compliance1
- Lab testing and methods1
- Regulatory submissions1
- Data and digital systems1
Company hiring pulse
Exelixis on Regulatory Jobs
- 20
- Open roles
- 20
- Distinct roles
- 2
- Locations
By discipline
- Clinical12 60%
- Quality5 25%
- Regulatory3 15%
By level
- Director15 75%
- Manager2 10%
- VP & Executive1 5%
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Drug Safety Associate II at Exelixis
Open until filled. $105K–$148K a year, employer provided.