Pharmacovigilance Tester

Job Role:

Work Experience:

Work location:

Mode of work:

Skills Required

• Experience in PV (Pharmacovigilance)
• Worked with Argus safety Or Aris tool.
• Experience in 21 CFR PArt 11
• Functional testing and User testing
• Also known as OQs and PQs
• Manual testing (additional knowledge of SQLs is plus)

Job Summary:

The Argus/IVP Tester is responsible for ensuring the seamless integration, accuracy, and performance of safety data management systems, particularly in relation to Oracle Argus and IVP (Intake Validation Platform). The role involves designing, executing, and maintaining test cases and scenarios that validate data migration, transformation, and interface functionality between Argus and IVP. The tester will also work closely with cross-functional teams, including developers, business analysts, and project stakeholders, to identify and resolve defects, ensure compliance with regulatory requirements, and maintain high-quality deliverables.

Essential Functions:

Test Planning and Design

• Develop and document detailed test plans, test scenarios, and scripts for Argus and IVP data migration, transformation, and interface testing.
• Create validation test protocols (VTPL) and user acceptance test (UAT) plans for system changes and updates.
• Collaborate with business analysts to understand functional requirements and identify testing needs.

Test Execution

• Perform end-to-end testing of data migration between Argus and IVP, ensuring accuracy and traceability of data transformations.
• Execute test cases for system functionality, data validation, and interface integration across multiple environments.
• Identify, log, and track defects to resolution while maintaining detailed documentation of testing outcomes.

Documentation and Reporting

• Author and maintain standard operating procedures (SOPs), user functional requirement specifications (UFRS), and test execution summaries.
• Generate and present comprehensive test reports, including defect analysis, risk assessments, and overall test coverage metrics.

Regulatory and Compliance

• Ensure all testing activities comply with relevant regulatory standards, such as GxP and FDA 21 CFR Part 11.
• Assist in preparing system validation documentation and support audits by providing testing artifacts and evidence.

Collaboration and Communication

• Work closely with the development and tools teams to suggest design updates and improvements for system performance and usability.
• Support change management processes, including Argus configuration changes and IVP intake modifications.
• Act as a liaison between project stakeholders to align expectations and deliverables.

Continuous Improvement

• Identify opportunities to improve testing processes, tools, and methodologies for enhanced efficiency and accuracy.
• Stay updated with industry best practices, tools, and regulatory changes impacting Argus/IVP testing.