PV Innovation & Transformation Consultant

Excelya; Brussel Hoofdstad; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Excelya is seeking a Pharmacovigilance leader to drive transformation across Global PV and optimize data governance in a regulated environment. You will manage PV processes, safety workflows, and system performance, partnering with Digital Technology and external vendors to deploy new tools.

You will lead cross-functional projects, translate business needs into process improvements, ensure GxP compliance, and foster change management across teams to deliver ambitious PV objectives.

Competenze

• Master's degree in Life Sciences, Pharmacy, Biomedical Sciences, Information Systems, or related discipline.
• 7–10 years of experience in Pharmacovigilance, PV systems, business transformation, pharmaceutical consulting, or related areas.
• Proven track record of leading cross-functional projects within global pharmaceutical or highly regulated environments.
• Strong expertise in pharmacovigilance operations, safety databases, regulatory requirements, and GxP compliance.
• Hands-on experience in Veeva Safety implementations, PV transformation programs, Agile/Lean Six Sigma/PMP methodologies, and collaboration with technology partners and digital teams.
• Solid knowledge of data governance, data integrity, quality management, and process optimization methodologies.
• Experience translating business needs into functional, operational, and technology-driven solutions.
• Understanding of digital transformation, AI, automation, and innovation opportunities in regulated environments.
• Excellent project leadership, stakeholder management, communication, and problem-solving skills, with the ability to manage multiple priorities independently.

Mansioni

• Lead cross-functional transformation and innovation projects across Global Pharmacovigilance, ensuring delivery of strategic and operational objectives.
• Drive continuous improvement initiatives to optimize PV processes, safety workflows, and system performance.
• Support the ongoing enhancement and post-implementation optimization of Veeva Safety and related business processes.
• Define project scope, deliverables, timelines, KPIs, and monitor progress to ensure successful execution.
• Translate business needs and operational challenges into effective process improvement and digital transformation initiatives.
• Develop and strengthen PV data governance frameworks while promoting data quality, integrity, and standardization.
• Ensure compliance with GxP requirements, regulatory expectations, and internal quality standards across PV operations.
• Identify, assess, and implement automation and AI-driven solutions to improve Pharmacovigilance efficiency and effectiveness.
• Partner with Digital Technology teams, Veeva, and external vendors to design, validate, and deploy new tools in regulated environments.
• Act as a key liaison between business and technical stakeholders, facilitating change management, stakeholder alignment, and adoption of new processes and technologies.

Conoscenze

Pharmacovigilance leadership

PV systems

Project management

Veeva Safety

Agile/Lean Six Sigma/PMP

Data governance

Formazione

Master's degree in Life Sciences/Pharmacy/Biomedical Sciences/IS

Strumenti

Veeva Safety platform

PV transformation tools

Descrizione del lavoro

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

The successful candidate will play a key role in driving innovation, optimizing pharmacovigilance processes and improving data governance following the implementation of a new safety database platform. This position requires a strong combination of pharmacovigilance subject matter expertise, project leadership and a consulting mindset, with the ability to bridge business operations, digital technology teams and external solution providers.

Key Responsibilities

• Lead cross-functional transformation and innovation projects across Global Pharmacovigilance, ensuring delivery of strategic and operational objectives.


• Drive continuous improvement initiatives to optimize PV processes, safety workflows, and system performance.


• Support the ongoing enhancement and post-implementation optimization of Veeva Safety and related business processes.


• Define project scope, deliverables, timelines, KPIs, and monitor progress to ensure successful execution.


• Translate business needs and operational challenges into effective process improvement and digital transformation initiatives.


• Develop and strengthen PV data governance frameworks while promoting data quality, integrity, and standardization.


• Ensure compliance with GxP requirements, regulatory expectations, and internal quality standards across PV operations.


• Identify, assess, and implement automation and AI-driven solutions to improve Pharmacovigilance efficiency and effectiveness.


• Partner with Digital Technology teams, Veeva, and external vendors to design, validate, and deploy new tools in regulated environments.


• Act as a key liaison between business and technical stakeholders, facilitating change management, stakeholder alignment, and adoption of new processes and technologies.

• Master's degree in Life Sciences, Pharmacy, Biomedical Sciences, Information Systems, or a related discipline.


• 7-10 years of experience in Pharmacovigilance, PV systems, business transformation, pharmaceutical consulting, or related areas.


• Proven track record of leading cross-functional projects within global pharmaceutical or highly regulated environments.


• Strong expertise in pharmacovigilance operations, safety databases, regulatory requirements, and GxP compliance.


• Hands-on experience in Veeva Safety implementations, PV transformation programs, Agile/Lean Six Sigma/PMP methodologies, and collaboration with technology partners and digital teams.


• Solid knowledge of data governance, data integrity, quality management, and process optimization methodologies.


• Experience translating business needs into functional, operational, and technology-driven solutions.


• Understanding of digital transformation, AI, automation, and innovation opportunities in regulated environments.


• Excellent project leadership, stakeholder management, communication, and problem-solving skills, with the ability to manage multiple priorities independently.

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique.

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’sleading mid-size CROwith thebest employee experience. Ourone-stop provider service modeloffering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.

Excelling with caremeans benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.