Director, Global PV Systems Configuration Management

Director, Global PV Systems Configuration Management

Are you energized by the opportunity to work with global stakeholders to design and support critical highly visible Pharmacovigilance Systems Configuration that have a global impact? If so, this Director, Global PV Systems Configuration Management role could be an ideal opportunity to explore.

The PV Systems group enables Global Safety to be ambitious for patients by linking Pharmacovigilance (PV) system users and Digital and Tech several key areas including - systems delivery and configuration, systems validation, and systems support. The key systems management activities include:

• Project Management
• Business Analysis
• Data Analysis
• Systems Validation
• Systems Support, Configuration and Maintenance
• Training

The Director of PV Systems Configuration Management manages one of the 3 teams within the overall PV Systems function. They ensure that the design, maintenance, configuration and support of the PV Systems supporting Global Safety to enable GSK to efficiently, timely, accurately, and consistently process cases, report cases to regulators and monitor the safety of our marketed products and investigational compounds.

Key Responsibilities:

* Manage a global team of system managers, project analysts and technical associates who design, maintain, and support the configuration of PV Computerized Systems and associated processes

* Contribute to the strategic PV systems roadmap for GSK

* Design, document, and maintain the strategy for managing systems configuration within Global Safety

* Proactively identify areas which would benefit from new systems and technology by maintaining awareness of industry trends and regulatory changes worldwide in pharmacovigilance

* Lead delivery of innovative technology to enable proactive, quality monitoring of human safety of our products while continuously improving operational efficiency

* Ensure PV systems are configured and validated to efficiently support business processes

* Develop business cases for new technologies or changes to existing systems which have a clear return on investment

* Contribute to a systems governance model for PV systems and ensure robust change control processes are in place to maintain system validation throughout the lifecycle

* Participate and lead new software/systems evaluations and systems upgrades

* Contribute to development and management of an operational model for front-line support for PV systems users

* Ensure adherence to GSK's computer system validation guidelines for development and maintenance of PV systems.

Why you?

Basic Qualifications:

• BS/BA in a scientific (including computer science, mathematics, or other relevant discipline), life-sciences, or medically related field or equivalent work experience.
• 10+ years of experience in the pharmaceutical industry in clinical development, pharmacovigilance, and information management.
• Experience in database management, systems analysis, and design.
• Experience in computer systems supporting drug safety.
• Experience in configuration management in a safety database; Logical thinking to map complex operational needs into robust, clear systems requirements.
• Working knowledge of medical and drug terminology.
• Experience in change management within central safety and local operating companies to drive forward new initiatives.
• Experience using or managing Oracle Argus Safety.

Preferred Qualifications:

• Excellent understanding of clinical safety, pharmacovigilance and clinical development processes and regulations.
• Thorough understanding of GSK's DTMS quality management framework and procedures or equivalent computer systems life cycle management.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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