Impact Quality Lead - Pharmacovigilance

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.

• 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 ICSRs, DSURs, RMPs, and REMS.

• 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.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.