Impact Quality Lead - Pharmacovigilance

Pauwels Consulting; Eigenbrakel; On-site; EUR 90,000 - 130,000; Full time

Job summary

Pauwels Consulting is seeking an Impact Quality Lead to implement and maintain a proactive pharmacovigilance compliance program for a global pharmaceutical client. Lead across post-marketing programs, ensure alignment with GVP, GCP, FDA, EMA, and ICH standards, and drive audits, remediation, and continuous improvement.

The role requires 8+ years in GVP QA or pharmacovigilance, a Life Sciences degree, and fluency in English. Collaboration across international teams and vendors is essential.

Qualifications

• Bachelor's degree in Life Sciences, Science, or Engineering.
• 8+ years of experience in GVP quality assurance, GVP auditing, or pharmacovigilance in biotech/pharmaceuticals.
• Expert knowledge of global regulatory requirements including GVP, GCP, FDA, MHRA, and ICH guidelines.
• Experience managing QA systems, including CAPA, deviation management, and audit processes.
• Ability to lead process improvements in international, transversal environments.
• Strong analytical and conceptual skills with high attention to detail.
• Fluent in English.

Responsibilities

• Maintain global quality oversight of the pharmacovigilance system and PV QA system.
• Provide expert guidance on regulatory expectations (GVP, GCP).
• Oversee patient-centric initiatives and phase IV data integrity during signal detection and risk management.
• Lead GVP audits and health authority inspections, manage remediation and findings.
• Manage vendor and partner compliance via KPIs and quality controls.
• Drive deviation management with root cause analysis and CAPA effectiveness.
• Ensure quality of safety outputs and associated documentation.

Skills

GVP knowledge

GCP knowledge

Pharmacovigilance

Audit management

CAPA

Risk management

Regulatory compliance

English fluency

Education

Bachelor's degree in Life Sciences

Tools

Veeva Systems

Argus

Job description

Our client, a global pharmaceutical organization, is looking for an Impact Quality Lead to implement and maintain a balanced, proactive approach to pharmacovigilance compliance. This role provides leadership across post-marketing programs and ensures that all safety activities meet international regulatory standards and industry best practices.

Responsibilities

• Maintain global quality oversight of the pharmacovigilance system and the pharmacovigilance quality management system.
• Provide expert guidance on GVP and GCP regulatory expectations, including FDA, EMA, and ICH standards.
• Oversee patient-centric initiatives and phase IV studies, ensuring data integrity during signal detection and risk management.
• Lead and host GVP audits and health authority inspections, managing remediation plans and audit findings.
• Manage vendor and partner compliance through the monitoring of KPIs, metrics, and quality control checks.
• Drive deviation management processes, including root cause analysis, CAPA implementation, and effectiveness evaluations.
• Ensure the quality and compliance of safety outputs such as IC…

Requirements

• You have a Bachelor's degree in Life Sciences, Science, or Engineering.
• You bring 8+ years of experience in GVP quality assurance, GVP auditing, or pharmacovigilance within the biotech or pharmaceutical industry.
• You possess expert knowledge of global regulatory requirements including GVPs, GCP, FDA, MHRA, and ICH guidelines.
• You have experience managing quality assurance systems, including CAPA, deviation management, and audit processes.
• You're able to lead process improvement initiatives and work effectively within international, transversal environments.
• You have strong analytical and conceptual skills with a high attention to detail.
• You are fluent in English.

Nice to Haves

• Master's degree in a scientific discipline.
• Experience with Veeva Systems and the Argus global safety database.