Principal Programmer Analyst – Pharmacovigilance Systems
Job ID: R-01335958
Employment Type: Full-Time
Work Mode: Fully Remote
Location: United States (Remote – North Carolina based candidates preferred)
Category: Clinical Research | Pharmacovigilance | Safety Systems
Experience Required: 5+ years
Work Schedule: Monday to Friday
About the Organization
Our Clinical Research Services team plays a vital role in accelerating the development of innovative therapies worldwide. As part of a leading global Contract Research Organization (CRO), the team supports complex clinical development programs through deep scientific expertise, advanced technology, and regulatory excellence across the PPD clinical research portfolio.
Role Overview
The Principal Programmer Analyst is a senior-level technical expert responsible for the design, development, maintenance, and optimization of pharmacovigilance (PV) and safety database systems. This role partners closely with PV business users, project teams, and clients to deliver high-quality safety reporting, data migrations, system enhancements, and analytics solutions in compliance with global regulatory standards.
This position is fully remote and supports global pharmacovigilance operations.
Key Responsibilities
Safety Systems & Reporting
Collaborate with Pharmacovigilance stakeholders to gather requirements and recommend technical solutions
Design, develop, and maintain standard, custom, and ad-hoc reports using built-in tools and SQL
Develop, validate, and support aggregate safety reports for regulatory submissions
Provide programming support for safety data review and analysis
System Administration & Enhancements
Administer and support PV/Safety databases, including configuration changes and dictionary upgrades
Liaise with safety system vendors to manage system upgrades, enhancements, and issue resolution
Troubleshoot and resolve end-user system queries and technical issues
Manage system changes in accordance with organizational change control procedures
Data Migration & Validation
Lead complex safety data migration initiatives, including creation of Data Migration Plans, Design Specifications, and Summary Reports
Ensure data integrity, completeness, accuracy, and regulatory compliance throughout migration activities
Validate migrated data to meet internal, client, and regulatory requirements
Compliance, Audits & Documentation
Assist in the development and maintenance of SOPs related to PV/Safety systems
Support internal and external audits, inspections, and regulatory inquiries
Ensure adherence to Good Manufacturing Practices (GMP) and global pharmacovigilance regulations
Leadership & Analytics
Act as a department-level technical lead for complex analytics and safety system projects
Provide consultancy and subject matter expertise across the pharmacovigilance function
Review and recommend process improvements to enhance system efficiency and data quality
Lead project initiatives, ensuring timely, high-quality delivery within scope and budget
Support effort estimation for bids, proposals, and cost modeling activities
Mentor and guide junior programmers and analysts
Education & Experience Requirements
Education
Bachelor’s degree or equivalent in Computer Science, Information Systems, Life Sciences, or a related discipline
Experience
Minimum 5+ years of relevant experience in pharmacovigilance systems, safety databases, or clinical research programming
Proven experience supporting PV operations within a CRO, pharmaceutical, or biotechnology environment
Required Technical Skills
Hands-on system administration experience with Oracle Argus Safety
Strong understanding of safety system configuration, database structures, mappings, and transformation rules
Advanced SQL programming and report development expertise
Demonstrated experience in safety data migration and validation projects
Strong knowledge of relational database structures and complex data environments
Proficiency in one or more programming languages used in clinical or safety systems
Core Competencies
Strong analytical and problem-solving abilities with exceptional attention to detail
Excellent written and verbal communication skills
Ability to manage multiple complex assignments with tight timelines
Adaptability to evolving priorities in a fast-paced environment
Proven leadership, initiative, and mentoring capabilities
Effective collaboration within cross-functional and multidisciplinary teams
Consistent delivery of high-quality work on time and within budget
Why Join This Role?
This role offers the opportunity to act as a senior technical authority within global pharmacovigilance operations while working fully remotely. You will influence safety system strategy, lead complex initiatives, and support the delivery of high-impact clinical programs in a dynamic, global CRO environment.
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