Lead Reports Developer - Pharmacovigilance Dru

About the Role:

Qaurs Techno Systems LLC is looking for a talented and driven Lead Reports Developer to join our growing team in Cumming, GA. This is an exciting opportunity to take ownership of reporting solutions, lead development initiatives, and make a real impact in a dynamic tech environment. If you're passionate about data, analytics, and building meaningful reports, we want to hear from you!

• Top 3 Must-Haves:

Argus Safety Database experience

• Expert-level Oracle SQL, PL/SQL, and Shell scripting
• Systems Validation (CSV), GxP Compliance, and 21 CFR Part 11 knowledge
• The ideal candidate will have 5–8 years of technical systems experience in database reporting, BI, or data warehousing, specifically working hands-on with Drug Safety systems and reporting tools (Argus, Insight, Cognos, Spotfire, or SSRS).

Job Description: Lead Reports Developer - Pharmacovigilance Drug Safety Systems

Objective / Purpose:

Provide expertise within the Global Pharmacovigilance group for the implementation and operation of all Global reporting solutions.

• Work collaboratively with Global Pharmacovigilance functions, IT teams, and Quality Assurance to ensure excellent and efficient reporting systems and end-user support.
• Provide strategic technical input into the planning, roadmap, and execution of PV Database reporting requirements, ensuring global regulatory requirements are met.
• Contribute to the oversight of any vendor-outsourced Global PV reporting activities.
• Accountabilities:

Proactively identify and document Global Pharmacovigilance reporting end-user system needs.

• Lead user needs/requirements analysis, supporting the build and maintenance of BI solutions using Oracle, Cognos, and/or other applicable technologies.
• Lead the execution, tuning, and optimization of Global reporting solutions and ad hoc query development.
• Lead complex system and data investigations supporting end-user inquiries.
• Provide strategic technical input into the definition of reporting development standards, procedures, and best practices.
• Perform audit and inspection support related to Global PV Reporting and Analytics.
• Provide mentoring, training, and best practices for ad-hoc query and other report developers.
• Education & Competencies:

Bachelor’s degree required; Advanced degree preferred.

• 5–8 years of technical systems experience required; preferably in Database Reporting, Development, Business Intelligence, or Data Warehousing.
• Experience with Pharmacovigilance Drug Safety Systems (Argus, Insight, Cognos, Spotfire, SSRS preferred), including underlying DB data models.
• Expert knowledge of database programming languages, concepts, and query tools, including Oracle SQL, PL/SQL, Windows and/or Unix Shell scripting.
• Strong understanding of SDLC, including requirements gathering, technical design, unit testing, and UAT.
• Experience with Computer Systems Validation (CSV), including 21 CFR Part 11 and GxP compliance in a regulated environment.
• Working knowledge of MedDRA and a general knowledge of the drug development process.
• Excellent analytical, written/verbal communication, and organizational skills

Note: Takeda(Client) requires the candidate's birth month and day (MM/DD) with all submissions

About Us:

Qaurs Techno Systems LLC is a technology-focused company based in Cumming, GA, dedicated to delivering innovative and reliable solutions to our clients. We pride ourselves on fostering a collaborative and forward-thinking work culture where talented professionals can thrive and grow. Our team is passionate about technology, and we're committed to building an environment where great work is recognized and rewarded.

This is a remote position.