Pharmacovigilance Specialist at Santhera Pharmaceuticals
Publication date:
14 March 2025Workload:
100%Contract type:
Unlimited employment- Place of work:Pratteln
Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on medical science and the development and commercialization of innovative pharmaceutical products for the treatment of rare neuromuscular diseases with high unmet medical need. For further information, please visit the Company's website www.santhera.com Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe impact on the lives of affected children and adults. You can make a difference as:
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
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.
