Senior Drug Safety IT Systems Manager

Alameda, CA, United States

SUMMARY/JOB PURPOSE:

The Senior Staff Engineer, Product Management - Business Applications will ensure high-quality Drug Development Business Applications support. The role will lead the delivery of Support, DevOps, and initiatives in Global Patient Safety (GPS) functions from a Drug Development perspective. Implements right-fit product and execution by collaborating with cross-functional IT teams, including IT security and business stakeholders, as well as regulatory compliance quality assurance (QA). Actively participates in planning sessions with key stakeholders to determine the scope and nature of business requirements and priorities to consider for the product & execution. Brings thought leadership to improving product quality and continuously maturing products. Works closely with cross-functional IT to achieve the IT team's vision, mission, and goals.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Participates in short- and long-term strategic planning sessions to improve business processes through capability development.

Demonstrates how capability enablement can assist departments/business areas and how platforms and solutions can support achieving short- and long-term business goals.

Performs lead activity, mentors team technically, participates in requirement gathering, & creating status reports for project deliverables.

Builds relationships with Managed Service Providers, cross-functional IT team, and Compliance QA.

Vigilantly safeguards Exelixis systems by implementing various IT Security initiatives.

Develops and manages the Global Patient Safety project portfolio . Aligns Global Patient Safety technology roadmap with information security, GxP compliance requirements, and enterprise IT architecture.

Keeps abreast of industry trends and advancements in relevant technology.

Supports agency and partner Audits and Inspections.

SUPERVISORY RESPONSIBILITIES:

Provides direction to Managed Service Provider resources.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Bachelor's degree in related discipline and 9 years of related experience; or

Master's degree in related discipline and 7 years of related experience; or

PhD degree in a related discipline and 2 years of related experience; or

Equivalent combination of education and experience.

EXPERIENCE/THE IDEAL FOR SUCCESSFUL ENTRY INTO JOB:

Cultivates and demonstrates an in-depth knowledge of Drug Development business capabilities focused on Patient Safety.

Experience working on various Pharmacovigilance systems, such as Argus, AE Intake systems, Literature Management, Signal Management, Reporting, including aggregate reporting, and Analytics (Tableau, Spotfire).

Must have experience with Confluence JIRA to execute Pharmacovigilance DevOps Projects.

Experience in database management, system analysis, design, and disaster recovery.

Experience is required in technology strategy, product design, engineering, platforms, data architecture, and analytics.

Experience with Agile, Scrum methodologies, and DevOps. Cloud certifications and AWS experience are highly desired.

Experience working with Computer System Validation in a GxP-regulated area.

Strong Delivery skills, ability to work in a complex environment, and influence cross-functional teams.

Experience working with SaaS applications and monitoring service levels and deployment schedules.

Experience managing a group of consultants for delivery and sustainment and ensuring the quality of deliverables.

Bridges the gap between business and IT.

Strong Listener: Listening patiently to understand the business needs.

Bachelor's degree in IT, CS, Business Process Management, or related discipline or an equivalent number of years of work experience.

KNOWLEDGE/SKILLS:

Thorough knowledge of all aspects of Pharmacovigilance systems, such as Argus, Axway, Signal Management, Reporting and Analytics (Tableau, Spotfire), EDC, and AWS.

Demonstrated ability to participate with businesses in launching technologies to support drug launches and deliver large, complex programs involving system and process reengineering and integration.

Strong knowledge of processes and global regulations for pharmacovigilance and signal management processes.

Good knowledge of PL/SQL and ability to write complex SQL queries.

Ability to analyze complex business problems and evaluate solutions. Ability to translate complex technical issues into business terms. Excellent analytical, problem-solving, and troubleshooting skills.

Applies strong analytical and business communication skills.

Ability to effectively manage competing priorities and timelines.

WORKING CONDITIONS:

Environment: primarily working indoors in buildings.

Physical effort/lifting, such as sedentary - up to 10 pounds.

Travel is not typically required.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $159,000 - $226,000 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. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

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.

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