Drug Safety Reporting Consultant

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.

About the Role

We are seeking a Consultant (Pharmacovigilance Reporting Consultant or Argus Safety Reporting Consultant) to join our team. As a Consultant, you will support clinical research by designing, developing, and validating reporting solutions that help Pharmacovigilance teams monitor patient safety, meet regulatory obligations, and make timely, data-driven decisions.

This position plays a key role in patient safety oversight, regulatory compliance, and the accuracy of safety data. You will collaborate with business analysts, Pharmacovigilance stakeholders, and technical teams, follow GxP-aligned, industry-standard processes, and contribute to reporting solutions from requirements gathering through deployment and production support.

Responsibilities include designing, developing, testing, and validating custom reports and dashboards in platforms such as IBM Cognos, Oracle Business Intelligence Enterprise Edition (OBIEE), JReport, Microsoft Power BI, and Oracle Argus Insight, Argus Mart, and Argus Analytics, with opportunities to deepen your expertise and influence the quality of safety insights.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through accurate, efficient, and user-friendly reporting that supports patient safety. With diverse teams and continuous learning opportunities, the Drug Safety Reporting Consultant can explore career paths and expand skills across Pharmacovigilance and clinical research.

Key Responsibilities

• Design, develop, customize, and maintain reports and dashboards that meet business and regulatory requirements, including reports for Oracle Argus Safety case management, expedited reporting, case processing, and regulatory submissions.
• Write and optimize complex SQL and PL/SQL queries, procedures, and views to extract, transform, and reconcile data from Oracle Argus Safety databases.
• Perform unit, functional, and data validation testing to confirm that report outputs match source data and that calculations, filters, and aggregations are accurate and compliant with GxP requirements and client validation procedures.
• Develop dashboards and visualizations that track key Pharmacovigilance metrics, including case volumes, processing timelines, and compliance indicators.
• Translate business and Pharmacovigilance requirements into technical specifications, design documents, test scripts, and validation documentation.
• Support User Acceptance Testing, incorporate business user feedback, and support report deployment, post-deployment verification, and production issue resolution.
• Troubleshoot data discrepancies, report execution failures, and performance issues, and tune queries to improve report execution time.
• Enhance existing reporting solutions and configure report scheduling and automated distribution to improve accuracy, usability, and efficiency.
• Support reporting activities during Argus upgrades, application enhancements, and database migrations.
• Identify opportunities to automate manual reporting activities and work with cross-functional teams to resolve Argus Safety data and reporting issues.

You'll thrive in this role if you bring

• Strengths in SQL, PL/SQL, and report development using tools such as IBM Cognos, OBIEE, JReport, or Microsoft Power BI.
• Experience working in drug safety, Pharmacovigilance, clinical research, or another regulated environment.
• The ability to collaborate across teams and communicate clearly with business analysts, Pharmacovigilance stakeholders, and global client teams.
• A patient-focused mindset and strong attention to detail, particularly in data accuracy and report validation.
• Comfort working with Oracle databases, Oracle Argus Safety data, and structured report validation processes.

Required Qualifications

• Bachelor’s or master’s degree in computer science, Information Technology, Engineering, or a related discipline.
• 4-6 years of experience in IT application development, reporting, BI development, or technical consulting.
• Hands-on experience developing and maintaining reports using at least one of the following: IBM Cognos Analytics or Report Studio, Oracle Business Intelligence Enterprise Edition (OBIEE), JReport, Microsoft Power BI, or Oracle Argus Insight, Argus Mart, or Argus Analytics.
• Strong knowledge of SQL and PL/SQL, including complex queries, joins, subqueries, functions, and stored procedures.
• Experience with Oracle databases and the report development lifecycle, including requirements analysis, design, development, testing, validation, and deployment.
• Good understanding of Pharmacovigilance business processes and Oracle Argus Safety database architecture, particularly Individual Case Safety Reports (ICSR).
• Strong communication, organization, and problem-solving skills.

Preferred Qualifications

• Exposure to aggregate and periodic safety reporting, such as Periodic Safety Update Reports (PSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), and Development Safety Update Reports (DSUR).
• Experience developing reports for adverse event case management, expedited regulatory reporting, or safety metrics and management dashboards.
• Familiarity with Cognos Framework Manager, OBIEE Repository (RPD), BI Publisher, Power BI DAX, and Power Query.
• Knowledge of ETL processes, data warehousing, and data modeling.
• Understanding of E2B (R2 and R3), Axway EDI Gateway, and Argus integrations.
• Exposure to Python, reporting automation, and data analytics.
• Knowledge of Snowflake and cloud-based reporting platforms.
• Exposure to GxP, 21 CFR Part 11, Computer System Validation (CSV), and software validation practices.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be perfect fit, send them the link to apply!