Consultant

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were 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 22000 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.

Youll 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.

Youll 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

• Bachelors or masters 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 doesnt sound like the next step in your career but perhaps you know of someone whod be perfect fit send them the link to apply!