Exelixis, Inc.
Drug Safety Associate II (Finance)
SUMMARY:
The Drug Safety Associate II is responsible for providing Drug Safety expertise and ensuring the quality documentation of safety data, particularly serious adverse events (SAEs); for supporting all major tasks related to the management and best utilization of the Argus Safety Database; and ensuring compliance with FDA/International Drug Safety regulations in all aspects of drug safety data processing and reporting.
Position Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Technical duties include but are not limited to:
• Processing and assessment of SAEs from receipt at Exelixis to case closure in the Argus database, including query generation and 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.
• Schedule submissions of expedited safety reports in ARGUS as needed.
• Collaborate with other Exelixis departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data.
SUPERVISORY RESPONSIBILITIES:
• None
EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline; or,
• MS/MA degree in related discipline; or,
• PhD in related discipline; or;
• BS or MS in Nursing, Pharmacy or other clinical degree, preferably in a health science field with a minimum of five years of clinical experience.
• Equivalent combination of education and experience.
• May require certification in assigned area.
Experience:
• BS/BA degree in related discipline; or,
• MS/MA degree in related discipline; or,
• PhD in related discipline; or;
• BS or MS in Nursing, Pharmacy or other clinical degree, preferably in a health science field with a minimum of five years of clinical experience.
• Equivalent combination of education and experience.
• May require certification in assigned area.
Experience:
• Minimum of three years of experience with a Drug Safety database - Argus preferred.
• Typically requires a minimum of five years of related experience and/or combination of experience and education/training.
• Experience in Biotech/Pharmaceutical industry and/or in oncology preferred.
Knowledge/Skills/Abilities:
• Working knowledge of relevant FDA and ICH guidelines, and of regulations governing safety reporting and processing.
• Familiarity with Drug Safety database. Prior use of Argus preferred.
• Trained and proven proficiency in MedDRA.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Performs a variety of complicated tasks with some degree of creativity and latitude.
• Has good understanding and wide application of technical principles, theories, concepts and techniques.
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Proficient with broad use computer applications such as MS Office and specialized applications as needed for job.
JOB COMPLEXITY:
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Networks with key contacts outside own area of expertise.
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.
Exelixis is an equal opportunity/affirmative action employer. We will consider all qualified applicants for employment without regard to race, color, religion, sex, age, or national origin.
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.