Tailored Pharmacovigilance Support

Structured, Independent, and Reliable

I work independently and bring structure and accountability to every task - ensuring reliable execution and smooth collaboration with your team.

Why Choose Me as Your Partner

PV Quality & Oversight – From a Single Source

I specialize in pharmacovigilance quality - with deep expertise in audits, PV processes, PSMF/PSSF, inspections, and PV agreements. You receive both strategic and operational support from a single, experienced source.

Pragmatic, Tailored Solutions

No copy-paste templates: I provide efficient, risk-focused solutions aligned with your specific setup - ensuring inspection-readiness at all times.

Flexible Support Without the Overhead

No long onboarding, no hidden costs. You get expert support exactly when you need it - without the commitment of full-time staff.

EU and Global Expertise

With extensive experience in European and international PV systems, I support companies entering the EU market or expanding globally. I understand the complex requirements placed on EU-QPPVs, national representatives, and local PV setups – ensuring full compliance with evolving regulatory standards and best practices for patient safety.

My services are based on a solid understanding of pharmacovigilance legislation and support the alignment of your PV system with EU GVP, relevant European Directives and Regulations, and internationally recognized guidelines.

I translate complex regulatory expectations - such as those introduced by Directive 2010/84/EU, Regulation (EU) No 1235/2010, Commission Implementing Regulation (EU) No 520/2012, and relevant ICH guidelines (including E2D, and E2B) - into practical, inspection-ready solutions.

From risk-based audit planning and deviation management to signal management and partner oversight, I help you create a PV system that not only fulfills formal requirements but truly protects patient safety.

Compliance Built on a Solid Regulatory Foundation

My Services

Pharmacovigilance Services – Strategic and Operational

Here is an overview of the pharmacovigilance services I provide to help ensure compliance, streamline processes, and support your operations efficiently.

PV Activities & Operations

Need operational support? I offer hands-on help for essential PV tasks – flexible, compliant, and with minimal onboarding required.

My support includes:

• Local Contact Person (LCP) services

• Literature and signal screening

• Data reconciliation

• Training and onboarding of internal teams

→ Discover the full service

PV System & Quality

I help you build, optimize, and maintain your pharmacovigilance system in compliance with EU GVP – from documentation to audits.

My key services:

• Risk-based audit systems & PV audits

• PSMF/PSSF creation and maintenance

• SOP development & deviation management

• CAPA planning & execution

• GDPR-compliant PV processes

• Inspection preparation and support

• PV agreement (PVA) negotiation and implementation

→ Discover the full service

PV Expertise & Consulting

Looking for expert guidance, tailored training, or support in managing external interfaces? I provide the strategic and hands-on expertise needed to strengthen your PV system across all enteties.

My expertise includes:

• Targeted PV training for internal teams

• Global PV system set-up, EU market entry, and partner management.

• Strategic consulting across all offered areas

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Let’s Make Your PV System Work - In Practice

I care about delivering solutions that work - not just on paper, but in your daily operations. With practical experience and a strong sense of responsibility, I help strengthen your PV system where it has the greatest impact.

Let’s talk about how I can support your business with tailored, practical, and compliant solutions - designed to ensure long-term PV success.