Global PV Database Reporting and Analytics Lead

Lancesoft; United States; On-site; USD 110,000 - 170,000; Full time

Job summary

Lancesoft seeks an experienced Pharmacovigilance Database Reporting specialist to support the Global PV group in implementing and operating global reporting solutions. You will partner with PV, IT, QA, and analytics teams to ensure compliant, scalable data delivery.

The role emphasizes expertise in Argus, BI reporting, and data warehousing, with a focus on validating systems per 21 CFR Part 11 and GxP. Strong SDLC knowledge and communication skills are essential to drive global regulatory

Qualifications

• Bachelor’s degree required
• 5–8 years of technical systems experience in Database Reporting/BI/Data Warehousing
• Experience with Pharmacovigilance Drug Safety Systems and BI Reporting Systems (Argus, Insight, Cognos, Spotfire, SSRS)
• Expert knowledge of Oracle SQL, PL/SQL, and scripting (Windows/Unix)
• Strong SDLC understanding (requirements, design, testing)
• Experience with Computer Systems Validation (21 CFR Part 11, GxP)
• Process-oriented focus
• Knowledge of drug development and PV regulations for PV computer systems
• Excellent analytical, written, and verbal communication skills
• Excellent organizational and time-management skills

Responsibilities

• Provide expertise within Global Pharmacovigilance for implementation/operation of Global reporting solutions
• Collaborate with Global PV functions, PV Database Reporting and Analytics Lead, IT teams and QA to ensure effective reporting systems and end-user support
• Provide strategic technical input into planning, roadmaps, and execution of PV database reporting/analytics requirements to meet regulatory requirements
• Oversee vendor outsourced Global PV reporting activities

Skills

Argus Safety Database

SQL

Systems Validation & GxP Knowledge

Education

Bachelor’s degree

Advanced degree

Tools

Insight

Cognos

Spotfire

SSRS

Job description

Top 3 skills: Argus Safety Database; SQL; Systems Validation & GxP Knowledge.

Objective / Purpose:

• Provide expertise within the Global Pharmacovigilance group for implementation / operation of all Global reporting solutions
• Work collaboratively with Global Pharmacovigilance functions, Global PV Database Reporting and Analytics Lead, support and validation roles, IT teams and Quality Assurance to ensure excellent and efficient Global reporting systems and end-user support
• Provide strategic technical input into planning, roadmap, and execution of the Global PV Database reporting and analytics systems’ requirements, ensuring Global regulatory requirements are met
• Contribute to oversight of any vendor outsourced Global PV reporting activities

Education & Competencies (Technical and Behavioral):

• 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, including underlying DB data models, and associated Business Intelligence Reporting Systems (Argus, Insight, Cognos, Spotfire, SSRS preferred) business support and/or maintenance
• Expert knowledge of database programming languages, concepts, and query tools, including Oracle SQL, PL/SQL, Windows and/or Unix Shell scripting, etc.
• Strong understanding of Software Development Life Cycle (SDLC), including requirements gathering, technical design, and unit to system and user acceptance testing
• Experience with Computer Systems Validation, including understanding of 21 CFR Part 11, GxP compliance and validation in a regulated environment
• Process oriented focus
• General knowledge of drug development process, including excellent knowledge of Pharmacovigilance regulations and guidance as applies to regulated PV computer systems
• Excellent analytical skills
• Excellent written and verbal communication skills
• Excellent organizational and time management skills