Who I Am – And How I Work

Audit Strategy & Execution

Deep experience in EU GVP Module IV audits, risk-based audit systems, and inspection support.

PV System & Quality Management

SOPs, PSMFs, reconciliation, CAPAs – built for compliance, usability, and long-term integrity.

Partner & Contract Oversight

50+ PV agreements negotiated, structured PV partner management, and regulatory alignment.

Operational PV Activities

ICSRs, literature screening, and local PV services delivered with precision and reliability.

Training & Consulting

Customized PV trainings, role-specific guidance, and regulatory consulting across EU and global PV systems.

My Professional Path

What started as a pharmacist’s responsibility for medication safety evolved into a deep specialization in PV Quality.

In public pharmacies, I worked as a Quality Manager (QB) and deputy manager of the pharmacy. These roles gave me the opportunity to take over responsibility, strengthened my awareness of activities related to medication safety, and gave me hands-on experience in maintaining and improving the Quality Management System (QMS) in line with German pharmacy regulations (ApBetrO). I developed a strong focus on customer satisfaction and service excellence – a client-centered mindset that remains key in my current work.

From hands-on case processing to overall PV system establishment, my path has equipped me with both the operational insight and the strategic foresight needed to deliver real impact. Over time, I specialized in PV Quality, with a particular focus on EU GVP Module IV. I have built, implemented, and optimized risk-based audit systems for both critical PV processes internally and external partner audits – always aiming to balance regulatory compliance, practical feasibility, and business efficiency.

Core Areas of Expertise - At a Glance

I bring hands-on expertise across the full pharmacovigilance system lifecycle – from strategic system design to operational execution and authority inspections. My focus lies in PV Quality, EU GVP compliance, and practical implementation that truly works.

Structured, analytical, and execution-focused – with strong intercultural collaboration skills.

→ Explore full profile & detailed expertise here

What Sets Me Apart

I bring structure, precision, decisiveness, and experience to every project. With my logical, structured, and practical mindset, I ensure my work is always efficient. My analytical and cautious nature helps me identify potential challenges early and address risks proactively.

What truly sets me apart is that I offer all services from a single source – hands-on, compliant, and with a deep understanding of PV Quality. There are no unnecessary overheads, no inflated teams – just reliable, focused work with a clear sense of purpose.

I strongly believe that there is not just one right way to approach a challenge. Every company, every situation, and every partner is different – and so are the solutions. I make it a priority to truly understand the needs and expectations of my clients and to find the individually right solution for each case.

Equally important is my dedication to building trust-based partnerships. By prioritizing clear communication and reliability, I create a solid foundation where clients feel supported and confident in achieving their goals.

Whether it’s strategic consulting or operational quality management, I combine my sense of order and reliability with a results-driven mindset. My focus is not just on planning processes but on implementing them effectively, ensuring my clients see measurable results.

My Motivation

As a freelancer, my goal is to support companies with both expertise and practical solutions. I’m committed to helping clients navigate the complexities of pharmacovigilance with clarity and confidence – always with a focus on ensuring patient safety.

What drives me is not just compliance, but real-world applicability. Too often, companies are presented with extensive documentation or expert input, yet still struggle to identify what truly matters or how to act on it. I focus on breaking down the essentials and providing clear, actionable guidance that clients can put into practice.

I aim to deliver realistic, efficient solutions that fit seamlessly into existing systems and support sustainable compliance.

Let’s Connect

If you’d like to learn more about me or explore how I can support you, I’d be glad to connect.