Drug Safety Associate II
Exelixis
Summary
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.
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
- 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.
Requirements
- 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 in Biotech/Pharmaceutical industry and/or in oncology preferred.
- Clinical trial and spontaneous adverse event processing experience.
- Experience using Argus safety database preferred.
- 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.
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Life & Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Company Stock Purchase
- Long-Term Incentives
- 15 Vacation Days
- 17 Paid Holidays
- Up to 10 Sick Days
Company overview
Exelixis, Inc. is an oncology-focused biotechnology company headquartered in Alameda, California, that specializes in the discovery, development, and commercialization of innovative cancer treatments. Founded in 1994, the company has evolved into a multi-platform cancer organization with a proven track record in the challenging biotech sector. Exelixis is best known for its flagship molecule cabozantinib, an inhibitor of multiple tyrosine kinases including MET, AXL, VEGF receptors, and RET, which has led to several approved drugs for difficult-to-treat cancers. The company's portfolio includes four approved drugs, with two derived from cabozantinib, and it maintains a robust pipeline of next-generation cancer treatments. With approximately 1,500 employees across five continents, Exelixis operates as a publicly traded company (NASDAQ: EXEL) and has established strategic alliances with major pharmaceutical and biotechnology partners. The company's mission centers on transforming science into new treatments that give cancer patients and their families hope for the future, with every employee united in this ambitious cause.