Exel
Drug Safety Associate II
Alameda, CA · Mid
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About 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).
- 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.
Responsibilities
- 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.
Requirements
- Additional duties and responsibilities as required.
- BS/BA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 5 years of related experience
- MS/MA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 3 years of related experience
- 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.
Nice 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.
Skills
- Knowledge of biotechnology/pharmaceutical sector.
- Knowledge of regulatory framework governing patient safety.
- Good interpersonal skills and understanding of differing views.
- Capable of following predefined procedures for specific tasks.
- Capable of identifying task-related challenges and prioritizing activity accordingly.
- 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:
Compensation
- 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.
Benefits
- 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.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.