Company Description

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.

Position Description:

This role is responsible for oversight and maintenance of distribution and global submission reporting rules of all safety reports requiring regulatory submission in the Global safety database for individual cases. This encompasses ownership of the tasks involved in global regulatory submissions, including determining or verifying country specific requirements by referring to the submission reporting rules matrix. Responsibilities of this role also include identifying the correct manner of reporting the case to regulatory agencies (either electronically or in paper format), communicating with internal team members, and maintaining compliance with worldwide regulatory reporting rules.

Position Requirements:

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Carrying out tasks pertaining to all aspects of ICSR submission within the Drug Safety Department, including but not limited to:
• Collaborate with other Exelixis Drug Safety colleagues and cross-functional departments (Clinical Development, Regulatory) to ensure accurate and timely case submissions.
• Develop and document the worldwide submission processes, ensure processes are updated due to ever-changing regulatory, study-specific and partner requirements, and provide cross-training to the Drug Safety department.
• Oversee and maintain and update Country-Specific Regulatory Requirements in compliance with worldwide regulatory reporting rules for individual case reporting.
• Manage case report submissions by monitoring the case workflow status and prioritizing the cases that requires expedited submission in working with Triage, Case Processing and Medical Reviewer
• Perform ICSR submission for expedited reports and submissions distribution emails to external Business Partners, Regulatory Agencies and internal team members.
• Monitor activities of CRO's and partners to ensure adherence and compliance with applicable SMPs, PVAs, and other contractual agreements involved in ICSR submissions.
• Provide metrics for the Monthly Compliance Summary Report for delivery to Exelixis and partner execute management, as required.
• In collaboration with Drug Safety Quality Management, provide input for late submission findings, ensuring resolution and implementation of corrective action(s) as required.
• Other responsibilities as assigned

SUPERVISORY RESPONSIBILITIES:
• Oversees Drug Safety Submissions team

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:
• BS/BA degree in related discipline and 8 years of related experience; or,
• MS/MA degree in related discipline and 6 years of related experience; or,
• PhD degree in related discipline and 3-5 years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience:
• Drug Safety and previous ICSR submissions experience required.
• Experience using Argus safety database preferred.

Knowledge/Skills:
• Proficient with broad use of computer applications such as MS Office and specialized applications as needed for the job
• Excellent written, verbal and interpersonal communication skills
• Good understanding of the legal/regulatory requirements in the pharmaceutical/biotechnology area
• Documentation and quality review skills
• Strong problem-solving skills
• Able to perform a variety of complicated tasks with some degree of creativity and latitude

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.

WORKING CONDITIONS:
• Environment: primarily working indoors, performing clerical work

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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.

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.