Senior Validation Consultant – Oracle Argus Safety at USDM Life Sciences

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany. 

Nature and Scope of Job

USDM is seeking an experienced Validation Consultant with expertise in Patient Safety Systems (Oracle Argus Safety)/Pharmacovigilance. Resource will support Patient Safety, Commercial, and Medical Affairs projects and activities related to continuous improvements initiatives.  

Primary Responsibilities

• Provide CSV support for client Oracle Argus Safety System.
• Ensure compliance with methodology and SOP’s and the use of relevant tools.
• Write the software validation deliverables and manage review and approval the documentation lifecycles.
• Ensure timely, open, and effective communication to relevant stakeholders. 
• Ensure that the project validation deliverables are complete and consistent with GDocP.
• Ensure project timelines are followed, and potential issues are communicated.
• Ensure that project-related issues and deviations are recorded in accordance with SOPs.
• Assist in resolving Computerized System Validation compliance issues
• Create and manage BIS / IT change controls.
• Assist in writing, reviewing BIS procedures and templates.

Additional Responsibilities

• Ensure timely, open, and effective communication to relevant stakeholders. 
• Ensure project timelines are followed, and potential issues are communicated.

Qualifications

• 10+ years’ experience working in Life Science industry either within IT or Quality overseeing CSV.
• Must have: Deep experience with Oracle Argus Safety and Veeva, Argus Safety certification preferred.
• Strong understanding of adverse event processing and reporting, including nuances critical to regulatory compliance.
• Knowledge of applicable regulations and guidelines (GxP, Sox, GDPR, etc.).
• Experience with designing processes and procedures.
• Excellent in working with the latest versions of MS Office software package.
• Experience with Veeva software systems or other systems like QualityDocs, QMS, etc.
• Ability to work autonomously, have a critical mind and excellent attention to detail and documentation. 
• Demonstrated ability to effectively communicate, and influence at multiple levels within multidisciplinary organization.
• Understanding of the industry landscape and global regulatory requirements.
• Fluently in English writing and oral communication.

Education & Certification Requirements

• Bachelor degree in Informational or Bio Engineering, or related domains.
• Argus Safety certification preferred

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job. 

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
• Travel to client site for onsite work as needed.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. 

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 

Compensation

Salary/Hourly Rate Range (W2): USD 100.00 - 110.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off. All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here:  https://usdm.com/careers