Posted in General Business 30+ days ago.
Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
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 related to the management and best utilization of case processing activities in the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations and Drug Safety department procedures in all aspects of drug safety case processing and reporting.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Technical duties include but are not limited to:
• 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
• Performing Safety Study Lead activities including
o Review of, Investigator Brochures, study protocols and participation on IND Annual Reports in support of the Drug Safety Physician.
o Development of study specific safety management plan from Exelixis Drug Safety template
o Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e. SAE data collection form and CRF)
o Perform SAE reconciliation, as required by safety management plan
• Training of new safety staff on Argus and case processing.
• 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.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
• BS/BA degree in related discipline and 7 years of related experience; or,
• MS/MA degree in related discipline and 5 years of related experience; or,
• PhD in related discipline and 0-2 years of related experience; or;
• Equivalent combination of education and experience.
• May require certification in assigned area.
• BS or MS in Nursing, Pharmacy or other clinical degree with a minimum of five years of clinical experience.
• Experience in Biotech/Pharmaceutical industry and/or in oncology preferred.
• Experience using Argus safety database preferred.
• Clinical trial and spontaneous adverse event processing experience.
• 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.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Creates formal networks involving coordination within Drug Safety department and with cross-functional teams.
• Environment: primarily working indoors, performing clerical work
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.
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.
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