Senior QA Manager, Pharmacovigilance
il y a 20 heures
**The Senior QA Manager, Pharmacovigilance (PV)**, is responsible for maintaining, developing, and monitoring the PV quality system to ensure compliance with regulatory requirements and internal standards. This role acts as the primary point of contact for Global Patient Safety (GPS)/PV functions regarding PV quality system management and supports cross-functional processes impacting PV quality system, including regulatory affairs, clinical and medical affairs, affiliates, etc. The position also contributes to promoting a Quality culture of continuous improvement.
**Main responsibilities**:
**Quality Documents Management**
- Acts as QA representative for GPS regarding Quality Documents Management.
- Ensures the maintenance of PV Quality Documents System by supporting their creation and update as per quality documents life cycle management.
**PSMF Maintenance**
- Manages timely update of the PSMF body and annexes listing quality documents, deviations audits findings, and CAPA updates
**Deviation and CAPA Management**
- Accountable for overall oversight on deviations and CAPA Plans related to or impacting the Ipsen PV system.
- Ensures continuous overview and monitoring of CAPA implementation by tracking progress, providing reporting, and escalating as needed
- Manages the QA review of PV deviations and consistency of CAPA Plans, across the organization at global and local level
**Audits and Inspections**
- Coordinates the preparation and hosting of pharmacovigilance external audits and inspections.
- Supports any pre-audit/pre-inspection request management.
- Acts as primary contact for requests PV Quality Management System and provides responses when observations are related to the PV Quality System
- Coordinates post
- audit and post-inspection activities
**Additional duties**
- Implements and tracks compliance KPIs related to QMS.
- Provides quality updates for EU QPPV oversight.
- Develops and delivers PV QMS training.
- Supports affiliates with guidances on PV QMS.
- Support periodic review of PV QMS
- Acts as the Subject Matter Expert within Global Quality and contributes to Quality objectives
**To be considered for this role, you will have**:
- Extensive experience in pharmacovigilance, including expertise in pharmacovigilance quality management and PV compliance management.
- Cross-functional working skills
- Good communication skills: oral-written
- Result oriented - drives execution and accountability
- Fosters team work
- Demonstrates agility and flexibility
- Fluent in English
LI-Hybrid
-
Pharmacovigilance Officer
il y a 1 semaine
Boulogne-Billancourt, France Excelya Temps pleinHybridOperations, PV & SafetyFull time Boulogne-Billancourt, Île-de-France, France OVERVIEW Description About the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an...
-
QA Monétique Senior – Tests
il y a 2 semaines
Boulogne-Billancourt, France Libellio Temps pleinUne entreprise de services numériques recherche un QA / homologateur / testeur monétique à Boulogne-Billancourt. Le candidat idéal a au moins 6 à 7 ans d'expérience, spécifiquement dans le domaine de la Monétique. Les responsabilités incluent la rédaction et l'exécution des tests, le suivi des anomalies et la création de rapports d'avancement....
-
Responsable Pharmacovigilance H/F
il y a 3 semaines
Boulogne-Billancourt, France Amarylys Temps pleinAmarylys recherche pour l'un de ses clients un(e) Responsable Pharmacovigilance (H/F) Vous êtes à la recherche d'une expérience professionnelle stimulante dans l'industrie pharmaceutique, au sein d'un environnement international en constante évolution, avec une forte dimension managériale ? Alors, postulez dès maintenant ! Vous serez le garant de la...
-
Testeur QA Automatisé Orienté Front-end
il y a 2 semaines
Boulogne-Billancourt, France HR-TEAM Temps pleinDans le cadre du renforcement de nos équipes, nous recherchons un Leader QA Automatisation (H/F) **Passionné et polyvalent, le Lead QA a pour mission**: - Manager l’équipe QA automation et testeurs technico/fonctionnels assignés à votre équipe Produit - Assurer la bonne communication et être porteur de la vision QA auprès des équipes scrum, le...
-
Pv Agreement Manager
il y a 18 heures
Boulogne-Billancourt, France IPSEN Temps plein**Title**: PV Agreement Manager **Company**: Ipsen Pharma (SAS) Main role & responsibility - Lead the implementation of Pharmacovigilance Agreements (PVAs) for all applicable Business Partnerships, in full compliance with all relevant pharmacovigilance legislation - Develop and implement a cross-functional business process for ensuring that all external...
-
QA Analyst
il y a 19 heures
Boulogne-Billancourt, France Netatmo Temps plein**Company Description** What do we do?** At Netatmo, we design connected objects for the home. Innovative, inspiring and elegantly designed, our products enable their users to live in a safer, healthier and more comfortable home. (And save energy too!). Since 2018, Netatmo has been part of the Legrand Group, one of the world leaders in electronic products...
-
Consultant intégration qualification CI/CD
il y a 2 semaines
Boulogne-Billancourt, France Collective.work Temps pleinVous rejoignez une équipe en charge des environnements d’intégration et de qualification pour accompagner la livraison et la mise en production d’applications stratégiques. Mission aux côtés du Lead, vous interviendrez comme véritable couteau suisse technique pour assurer le déploiement, l’automatisation et le support aux équipes de...
-
Senior Brand Manager
il y a 2 semaines
Boulogne-Billancourt, France General Mills Temps plein: Il se passe toujours de grandes choses au sein de la région Europe et Australie (EUAU). Chaque jour, plus de 4000 collaborateurs partagent leur passion que ce soit dans nos bureaux, nos sites de fabrication, notre centre de R&D ou encore nos différents marchés à travers l'Europe, l'Australie et la Nouvelle-Zélande. Nous sommes animés par notre raison...
-
Pharmacovigilance Regulatory Compliance Unit Officer
il y a 7 jours
Boulogne-Billancourt, France Excelya Temps plein**About the Job** Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a...
-
Tester QA Homologation Jeux
il y a 1 semaine
Boulogne-Billancourt, France FDJ Gaming Solutions France Temps pleinInternship Boulogne-Billancourt (92) **Internship Description**: Intégré(e) au sein du département Interactive Games ainsi qu'en étroite collaboration avec le Producer, le lead QA et l'équipe de développement, vous interviendrez sur trois axes différents: - Les Tests QA, avec le report et le suivi des bugs, la mise à jour et l'exécution des plans...
