Remote as Argus Safety Pharmacovigilance Analytics

Job Title: Senior Pharmacovigilance Reporting & Analytics Consultant

100% Remote | 12 Months Contract

Ideal Candidate

• The ideal candidate will have deep expertise in Argus Safety, Pharmacovigilance reporting, Oracle SQL/PL-SQL development, and validated GxP systems, along with experience supporting global drug safety organizations in a regulated pharmaceutical environment. They will possess strong analytical skills, reporting expertise, and the ability to collaborate across business, IT, validation, and quality functions to deliver high-quality reporting and analytics solutions.

 

Objective / Purpose

• Provide technical expertise within the Global Pharmacovigilance (PV) organization for the implementation, support, enhancement, and optimization of Global PV reporting and analytics solutions. The consultant will partner with business stakeholders, IT teams, validation teams, and quality organizations to ensure efficient, compliant, and scalable reporting systems that support global drug safety operations and regulatory reporting requirements.
• The successful candidate will contribute to strategic planning, roadmap development, reporting solution design, analytics initiatives, and operational support of Pharmacovigilance reporting systems while ensuring compliance with global regulations and industry best practices.

 

Pharmacovigilance Reporting & Analytics

• Gather, analyze, and document reporting requirements from Global Pharmacovigilance stakeholders.
• Design, develop, maintain, and optimize reporting and analytics solutions supporting global drug safety operations.
• Develop custom reports, dashboards, and ad-hoc queries utilizing Argus Safety and related reporting platforms.
• Support implementation and enhancement of Business Intelligence (BI) capabilities including reporting, analytics, dashboards, and data visualization solutions.
• Collaborate with business users to translate reporting requirements into technical solutions.

Database Development & Reporting

• Develop and maintain Oracle SQL and PL/SQL-based reporting solutions.
• Perform data analysis, data validation, and complex data investigations.
• Optimize database queries and reporting performance through tuning and best practices.
• Support report migration, deployment, and maintenance activities.
• Develop automated reporting processes to improve operational efficiency.

Systems Support & Compliance

• Provide production support for Global Pharmacovigilance reporting systems.
• Investigate and resolve system, reporting, and data-related issues.
• Support system validation activities, including requirements documentation, testing, defect management, and user acceptance testing.
• Ensure compliance with GxP regulations and 21 CFR Part 11 requirements.
• Support regulatory inspections, audits, and quality assessments.

Strategic & Operational Support

• Contribute to reporting strategy, roadmap planning, and technology enhancement initiatives.
• Assist in establishing reporting standards, development methodologies, and best practices.
• Support vendor-managed reporting activities and ensure quality deliverables.
• Develop and report quality metrics related to Global PV reporting services.
• Mentor junior developers and reporting analysts on reporting standards and best practices.

 

Required Qualifications

• Bachelor's degree in Computer Science, Information Systems, Life Sciences, Pharmacy, or related field.
• Advanced degree preferred.

Experience

• 5-8+ years of experience in Database Reporting, Business Intelligence, Analytics, or Data Warehousing.
• Experience supporting Pharmacovigilance or Drug Safety systems within a pharmaceutical or biotech environment.
• Hands-on experience working with validated systems in regulated environments.
• Proven experience supporting global reporting and analytics initiatives.

 

Drug Safety & Pharmacovigilance Systems

• Strong experience with Oracle Argus Safety.
• Experience working with Pharmacovigilance reporting databases and data models.
• Knowledge of adverse event and drug safety reporting processes.
• Experience with Argus Insight and related reporting platforms preferred.

Database & Development

• Strong Oracle SQL expertise.
• Advanced PL/SQL development experience.
• Experience with database performance tuning and optimization.
• Knowledge of Windows and/or Unix Shell Scripting.

Reporting & BI Tools

Experience with one or more of the following:

• Cognos
• Spotfire
• SQL Server Reporting Services (SSRS)
• Oracle Reporting Platforms
• Business Intelligence and Analytics solutions

Validation & Compliance

• Strong understanding of SDLC methodologies.
• Computer System Validation (CSV) experience.
• Knowledge of:
  • 21 CFR Part 11
  • GxP Compliance
  • Validation Documentation
  • UAT/Test Execution

 

Required Domain Knowledge

• Pharmacovigilance (PV)
• Drug Safety Operations
• Adverse Event Reporting
• Regulatory Reporting Requirements
• Global Safety Database Operations
• MedDRA Coding Standards
• Drug Development Lifecycle

 

Required Soft Skills

• Excellent analytical and problem-solving skills.
• Strong written and verbal communication abilities.
• Ability to work independently and within global cross-functional teams.
• Strong organizational and time-management skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience collaborating with business stakeholders, IT teams, QA, and external vendors.

 

Preferred Qualifications

• Advanced degree in Life Sciences, Computer Science, or related field.
• Experience with Argus Insight Reporting.
• Experience with Spotfire Dashboard Development.
• Experience supporting global Pharmacovigilance organizations.
• Vendor management and oversight experience.
• Experience leading reporting strategy and analytics initiatives.
• Knowledge of automated reporting and process improvement methodologies.