Drug Safety Associate III

Exelixis

. Process and assess serious adverse events from receipt at Exelixis through case closure in the Argus database .

Posted 10/9/2026full-timeRemote • United StatesSeniorLead💰 $130,500 - $185,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in processing and assessing serious adverse events, including MedDRA coding and case quality review. Proficient in using the Argus Safety Database and collaborating across clinical and regulatory functions to ensure compliance and quality in drug safety documentation.

Highest-signal resume keywords

MedDRA Coding KnowledgeArgus Safety Database ExperienceClinical Trial Adverse Event ProcessingDrug Safety ExpertiseRegulatory Framework Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Serious Adverse Event ProcessingAdverse Event AssessmentCase Quality ReviewSafety Study Lead ActivitiesSafety Management Plan DevelopmentAnalytical Problem-SolvingDrug Safety Case Processing Procedures

Soft Skills

Clear Verbal CommunicationWritten Communication SkillsOrganizational CapabilitiesInterpersonal SkillsCollaborative Teamwork

Certifications & Qualifications

Certification in Assigned Area

Industry Keywords

Biotechnology SectorPharmaceutical SectorOncologyRegulatory ComplianceDrug Safety Documentation

About the role

Key responsibilities & impact

Process and assess serious adverse events from receipt at Exelixis through case closure in the Argus database
Generate queries, narratives, and ASE writings
Perform MedDRA coding of serious adverse events and adverse events
Develop and revise Exelixis MedDRA Coding Conventions
Define and apply high standards for case quality review with support from the Drug Safety Physician
Schedule expedited safety report submissions in Argus as needed
Train new safety staff on Argus and case processing
Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management
Perform Safety Study Lead activities, including reviewing Investigator Brochures and study protocols and participating in IND Annual Reports
Develop study-specific safety management plans from the Exelixis Drug Safety template
Develop, review, update, and harmonize drug safety forms and templates with clinical operations forms and templates
Perform SAE reconciliation as required by the safety management plan
Provide Drug Safety expertise and ensure quality documentation of safety data
Support and oversee outsourced vendors and drug safety study operational activities from study start-up through closeout
Identify and escalate issues with broader impact
Implement solutions for task-related challenges

Requirements

What you’ll need

BS/BA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 7 years of related experience; or MS/MA degree and a minimum of 5 years of related experience; or PhD and 0 or more years of related experience; or equivalent combination of education and experience
May require certification in assigned area
Experience in clinical trial and spontaneous adverse event processing
Knowledge of the biotechnology/pharmaceutical sector
Knowledge of the regulatory framework governing patient safety
Experience in the biotech/pharmaceutical industry and/or oncology preferred
Experience using the Argus Safety Database preferred
Ability to process and assess serious adverse events and adverse events
MedDRA coding knowledge
Ability to follow drug safety case processing and reporting procedures
Analytical problem-solving ability
Organizational and planning capabilities
Clear verbal and written communication skills
Ability to work collaboratively with team members
Good interpersonal skills
Ability to identify and escalate issues
Ability to train on procedures, tasks, and tools; may mentor junior team members

Benefits

Comp & perks

401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Opportunity to purchase company stock
Long-term incentives
15 accrued vacation days in the first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Necessary equipment, including dual monitors and ergonomic chairs
Disability accommodation support during the recruiting process