Impact Quality Lead - Pharmacovigilance
Company: Pauwels Consulting Agency
- Location: Braine-l’Alleud, Belgium
- Seniority: Director
- Employment type: Full-time
- Posted: 15 days ago
- Offer language: English
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 ICSRs, DSURs, RMPs, and REMS.
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.
