Pharmacovigilance Expert, Quality Management Specialist, EU GVP Professional

Experienced pharmacovigilance freelancer specializing in EU GVP, PV Quality, and regulatory compliance. My expertise includes audits, CAPA management, process implementation, training, partner management, and consulting for pharmaceutical companies.

• CAPA Management
• Inspection Preparation & Support
• Local Contact Person Services
• Manager pharmazeutische Industrie7 J.
• Pharmacovigilance Auditor
• Process Implementation & SOP Development
• PSMF/PSSF Management
• PV Agreements (DSA) Negotiation
• PV Training & Consulting
• Risk-Based Audit System Implementation

As a pharmacovigilance professional with a strong focus on EU GVP compliance, I offer comprehensive services tailored to meet the needs of pharmaceutical companies.

I am specialized in PV Quality, providing end-to-end solutions for all stages of pharmacovigilance processes. My expertise spans across PV audits, CAPA management, the creation and implementation of risk-based audit systems, and the preparation and support of inspections. I also support the creation and maintenance of standard operating procedures (SOPs) and process implementation in PV and quality-related topics. Additionally, I am experienced in the creation and maintenance of Pharmacovigilance System Master Files (PSMF) and Pharmacovigilance System Summary Files (PSSF), ensuring that all regulatory requirements are met for both local and global markets. I am also skilled in negotiating pharmacovigilance agreements (DSAs), tailoring contracts to align with regulatory expectations.

I am adept at balancing operational needs with regulatory requirements. My experience includes managing local literature searches, signal management, and case processing. I have conducted and reviewed over 100 audits, pre-qualified PV partners, and led numerous partner meetings to ensure alignment with regulatory expectations.

I am also highly experienced in delivering targeted PV training for teams and stakeholders. My extensive background allows me to guide companies in optimizing their pharmacovigilance systems, ensuring compliance, and maintaining the highest standards of quality.

In addition to my professional qualifications, I am a team-oriented individual who values collaboration and clear communication. I aim to provide cost-effective solutions without compromising on the quality of services offered. By working with me, clients can be assured of a reliable, structured, and regulatory-compliant approach to pharmacovigilance.

Whether you are a small pharmaceutical company looking to establish PV systems, a mid-sized enterprise in need of temporary support, or a service provider requiring expert assistance, I can help you meet your regulatory requirements.