Responsible for providing operational support to the Drug Safety Department in various areas that include administrative support and database (Argus) administration assistance. Assist in establishing and maintaining the most effective organization of the Drug Safety Department and assist with ensuring compliance with Clinical safety and pharmacovigilance regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Management and oversight of incoming SAE/ADR reports in the Drug Safety department
• Perform case book-in
• Perform QC of cases, reports, and other documents
• Provide support at the Department level (department calendar, etc.)
• Train new Drug Safety Operation Associates
• Assist with the management of validation documentation
• Manage Investigator List in Argus
• Submit and track expedited reports as needed
• Schedule submissions for expedited reports as needed
• Perform adverse event reconciliation as needed
• Unblind subjects from clinical trials as needed
• Generate Drug Safety adverse event listings for internal company use as needed
• Assist with obtaining follow-up for adverse events as needed
• Additional duties and responsibilities as required
• High school diploma or general education degree (GED) and six years of experience; or, AA degree and five years of related experience; or,
• BS/BA degree in related discipline and three years of related experience; or,
• MS/MA degree in related discipline and one year of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.
• Typically requires a minimum of six-eight years of related experience and/or combination of experience and education/training.
• Drug Safety or Clinical Trial experience preferred.
• Experience using Argus safety database preferred.
• Proficient with broad use of computer applications such as MS Office and specialized applications as needed for the job
• Written, verbal and interpersonal communication skills
• Good understanding of the legal/regulatory requirements in the pharmaceutical/biotech area
• Documentation and quality review skills
• Problem solving skills
• Able to perform a variety of complicated tasks with a wide degree of creativity and latitude
• 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.
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.