Impact Quality Lead, Pharmacovigilance
Enregistrez cette offre et organisez votre recherche
Créez un compte gratuit pour enregistrer des offres d'emploi, créer des alertes et revenir à cette liste depuis votre tableau de bord.
En continuant, vous acceptez nos Conditions d’utilisation & Politique de confidentialité.
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.
- 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.
- Master's degree in a scientific discipline.
- Experience with Veeva Systems and the Argus global safety database.
-
Impact Quality Lead
Il y a 2 jours
Eigenbrakel, Waals-Brabant, Belgique Pauwels Consulting Temps plein 90 000 € - 130 000 € ContratOur 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...
-
Impact Quality Lead GVP
Il y a 4 jours
Eigenbrakel, Waals-Brabant, Belgique UCB Temps plein 80 000 € - 120 000 € ContratImpact Quality Lead – Braine l’Alleud, Belgium About The Role As Impact Quality Lead you will be part of the Impact Quality team within RDPVQ. The Impact Quality Lead is a global role responsible for implementing and maintaining a balanced, proactive, global approach to pharmacovigilance (PV) compliance. This position is primarily responsible for...
-
Pharmacovigilance Inspection Management Lead F/M/X
Il y a 2 jours
Eigenbrakel, Waals-Brabant, Belgique AMARIS GROUP SA Temps plein 90 000 € - 130 000 € ContratPharmacovigilance Inspection Management Lead F/M/XOtherThe position is part of the Impact Quality team, supporting global pharmacovigilance (PV) activities and inspections. The main focus of this specific role is inspection management and inspection readiness, ensuring compliance with global regulatory requirements (GVP, GCP, GLP).Your missionsDrive...
-
Global Complaint Quality Lead — Hybrid, Strategic Impact
Il y a 3 jours
Eigenbrakel, Waals-Brabant, Belgique Randstad Belgium Temps plein 110 000 € - 150 000 € ContratRandstad Belgium is seeking a Complaint Quality Lead to drive the global GMP complaint management process and ensure regulatory compliance for biopharmaceutical products. You will be the primary expert contact for global teams and external partners, building a governance model for continuous improvement.You will oversee the outsourced central complaint unit,...
-
Impact-Driven Global PV Quality Lead
Il y a 5 jours
Eigenbrakel, Waals-Brabant, Belgique UCB Temps plein 80 000 € - 120 000 € ContratUCB is seeking an Impact Quality Lead in Braine l’Alleud, Belgium, responsible for overseeing pharmacovigilance compliance and quality systems. The ideal candidate has a Bachelor's degree in Science or Engineering, 12+ years of experience in GVP Quality Assurance and Auditing, and strong analytical and communication skills. This role supports...
-
Pharmacovigilance Inspection Management Specialist F/M/X
Il y a 4 jours
Eigenbrakel, Waals-Brabant, Belgique Amaris Consulting | Part of Mantu Temps plein 85 000 € - 110 000 € ContratJob DescriptionThe position is part of the Impact Quality team, supporting global pharmacovigilance (PV) activities and inspections. The main focus of this specific role is inspection management and inspection readiness, ensuring compliance with global regulatory requirements (GVP, GCP, GLP).Drive inspection readiness activities for global pharmacovigilance...
-
Evidence Quality Lead
Il y a 4 jours
Eigenbrakel, Waals-Brabant, Belgique UCB Temps plein 90 000 € - 150 000 € ContratSelect how often (in days) to receive an alert: Evidence Quality Lead Location: Braine L'alleud, Walloon Brabant, BE Job Function: Quality Assurance Job ID: 92445 Make your mark for patients To strengthen ourGlobal QualityAssurance department, we are looking for a talented professional to fill the position of:Evidence Quality Lead – Braine l’Alleud,...
-
Complaint Quality Lead
Il y a 3 jours
Eigenbrakel, Waals-Brabant, Belgique Randstad Belgium Temps plein 110 000 € - 150 000 € ContratAre you looking for a strategic opportunity to transform global quality governance? As a Complaint Quality Lead, you drive the corporate complaint management process and ensure regulatory compliance for biopharmaceutical products. You serve as the primary expert contact for global teams and external partners.Key responsibilities :You serve as the Complaint...
-
Complaint Escalation Management Quality Lead
Il y a 2 jours
Eigenbrakel, Waals-Brabant, Belgique UCB Temps plein 120 000 € - 150 000 € ContratComplaint and Escalation Management Quality Lead – Braine l’Alleud, Belgium About The Role As part of the Global Quality Organization, reporting to the Head of Complaint and Escalation Management, you will have oversight responsibilities for our complaints management Service Provider, as well as identifying and leading continuous improvement initiatives...
-
Benelux CQA Specialist — Quality
Il y a 4 jours
Eigenbrakel, Waals-Brabant, Belgique Vantive Temps plein 62 000 € - 90 000 € ContratVantive seeks a CQA Specialist to ensure compliance across regulatory licenses (WDA & MIA) and quality systems within the Benelux. You will coordinate with Regulatory Affairs, Pharmacovigilance and logistics to maintain certifications such as ISO 9001 and ISO 13485.You will lead post-market surveillance, support quality initiatives, and act as a back-up...