Pharmacovigilance Specialist at Santhera Pharmaceuticals
Santhera Pharmaceuticals (Schweiz) AG
Date de publication :
14 mars 2025Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Pratteln
Résumé de l'emploi
Santhera Pharmaceuticals est une entreprise suisse spécialisée dans les médicaments. Rejoignez-nous pour offrir des options de traitement aux patients atteints de maladies rares.
Tâches
- Améliorer le système de pharmacovigilance à l'échelle mondiale.
- Superviser les procédures de pharmacovigilance et la formation des employés.
- Participer aux audits et inspections réglementaires de la pharmacovigilance.
Compétences
- Minimum 2 ans d'expérience en pharmacovigilance internationale.
- Excellentes compétences en communication et en réseautage.
- Capacité à travailler de manière autonome et en collaboration.
Est-ce utile ?
GVP QA Manager
Location: Pratteln, Switzerland (Hybrid) Scope of Work
As a GVP QA Manager at Santhera, you will play a crucial role in maintaining and enhancing our global Pharmacovigilance (PV) System. Your work will ensure that Santhera meets its legal PV obligations as both a Marketing Authorization Holder and a Sponsor of clinical trials. In this role, you will help strengthen oversight, improve processes, and maintain compliance with international regulations. You will facilitate the implementation of high-quality PV procedures, support audits and inspections, and collaborate with internal and external stakeholders to ensure a robust and effective PV System. Please note: We are open to considering candidates who prefer a part-time arrangement (minimum 50% workload). If you are interested in a part-time role, please indicate your preferred working hours in your application. Key Responsibilities
- Continuously review and improve Santhera's global PV System.
- Ensure timely release and updates of PV procedures, including oversight of training completion.
- Oversee PV procedures and standards at both global and local levels.
- Act as Santhera's PSMF Coordinator.
- Contribute to the annual PV Audit Plan and implement necessary updates.
- Support PV-related audits, third-party assessments, and regulatory inspections.
- Draft and oversee CAPA plans to address audit findings, inspections, and deviations.
- Monitor and manage the execution and closure of CAPA plans.
- Identify and escalate overdue CAPAs or those at risk.
- Track and analyse GVP-related KPIs, contributing to Santhera's Quality Council.
- Assist in the development, review, and maintenance of PV Agreements and Service Agreements with vendors.
- Minimum 2 years of experience in international Pharmacovigilance.
- Strong knowledge of quality systems and PV compliance.
- Experience with PV audits and/or regulatory inspections.
- Deep understanding of European Drug Safety and Pharmacovigilance requirements (global knowledge is a plus).
- Fluent in English (written and spoken); additional languages are an asset.
- Strong attention to detail and commitment to quality.
- Excellent communication, interpersonal, and networking skills.
- Ability to work independently and collaboratively in a matrix environment.
- Strong time management, planning, and organizational skills.
- Proactive, accountable, and adaptable to changing priorities.
