Data Scientist Architect - Pharmacovigilance

Job Title:

Data Scientist Architect - Pharmacovigilance

Job Function:

Architect

Location:

Remote

About USDM

USDM Life Sciences is an AI solutions and process automation company built for life sciences — helping pharmaceutical, biotech, and medical device organizations put AI to work across real workflows and scale it safely. With 25 years of deep domain expertise and 900+ global clients, we have the capability to build and deploy AI into regulated environments backed by the governance practice that makes every deployment defensible under FDA, GAMP 5, and emerging AI regulations. Our proprietary TRUST-AI Framework guides clients from AI readiness through governed deployment to enterprise scale.

From strategy through implementation and adoption, we have delivered thousands of GxP projects globally — and we are leading the industry's next evolution. Through partnerships with Microsoft, Google, Oracle, Box, DocuSign, and more, our team helps connect technology, people, and data in ways that generate real outcomes for the organizations that make, regulate, and bring life-saving products to market.

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

Nature and Scope of Job

The Pharmacovigilance Data Scientist Architect will provide expertise within the Global Pharmacovigilance group for implementation/operation of all Global reporting solutions. Work collaboratively with Global Pharmacovigilance functions, Global PV Database Reporting and Analytics Lead, support and validation roles, IT teams and Quality Assurance to ensure excellent and efficient Global reporting systems and end-user support. Provide strategic technical input into planning, roadmap, and execution of the Global PV Database reporting and analytics systems’ requirements, ensuring Global regulatory requirements are met. Contribute to oversight of any vendor outsourced Global PV reporting activities

Primary Responsibilities

• Proactively identify / document Global Pharmacovigilance reporting end-user system needs and requirements
• Provide strategic technical input into development of roadmaps / plans for implementing complete range of Business Intelligence (BI) capabilities (reporting, analysis, dashboards,
• etc.) in response to Global Pharmacovigilance requirements and related driving Regulatory
• guidance
• Lead / perform user needs / requirements analysis, supporting build / maintenance of BI solutions, using Oracle, Cognos, and/or other applicable technologies, including definition of requirements, designs, source code development, unit testing, maintenance, and migration
• Lead / execute tuning / optimization of Global reporting solutions, including identifying / mitigating risks in proposed solutions
• Lead / execute Global custom report and/or Global ad hoc query development
• Contribute to prioritization, planning, and execution of global reports
• Lead complex Global system and data investigations, supporting end-user inquiry and/or Global Pharmacovigilance requirements
• Provide strategic technical input into the definition / documentation of Global reporting development and related process standards, procedures, best practices
• Research and/or contribute to implementation of automated processes, driving improved overall efficiency in all areas of Global PV Reporting and Analytics service delivery
• Perform audit / inspection support related to Global PV Reporting and Analytics
• Development, tracking, and reporting of quality metrics for Global PV reports
• Provide strategic technical input / support of Global PV DB Reporting and Analytics technology projects as required
• Provide mentoring, training and best practices for ad-hoc query and other Global report developers

Additional Responsibilities

• Performs other related duties and assignments as required

Qualifications

• 5 – 8 years of technical systems experience required; preferably in Database Reporting, Development, Business Intelligence, or Data Warehousing
• Experience with Pharmacovigilance Drug Safety Systems, including underlying DB data models, and associated Business Intelligence Reporting Systems (Argus, Insight, Cognos, Spotfire, SSRS preferred) business support and/or maintenance
• Expert knowledge of database programming languages, concepts, and query tools, including Oracle SQL, PL/SQL, Windows and/or Unix Shell scripting, etc.
• Strong understanding of Software Development Life Cycle (SDLC), including requirements gathering, technical design, and unit to system and user acceptance testing
• Experience with Computer Systems Validation, including understanding of 21 CFR Part 11, GxP compliance and validation in a regulated environment
• Process oriented focus
• General knowledge of drug development process, including excellent knowledge of
• Pharmacovigilance regulations and guidance as applies to regulated PV computer systems
• Excellent analytical skills

Education & Certifications

• Bachelor’s degree required; Advanced degree 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.

Equal Opportunity Statement

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 80.00 - 90.00

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.