Pharmacovigilance Services
Risk-Based Audit System
Development and maintenance of a GVP Module IV-compliant audit strategy - customized to your organizational structure and compliance requirements.
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Pharmacovigilance Audits
Full-scope support for pharmacovigilance audits: planning, execution, reporting, and CAPA follow-up.
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PV Agreements (PVAs)
Drafting, reviewing, and negotiating safety agreements in line with applicable EU and local requirements - ensuring roles, timelines, and data exchange processes are clearly defined.
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PSMF & PSSF
Creation and maintenance of Pharmacovigilance System Master Files and Sub-System Files - accurate, inspection-ready, and aligned with actual processes.
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SOP Development & Maintenance
Authoring, revising, and performing gap analysis of PV procedures - based on regulatory expectations and practical workflows.
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PV System & Quality
A solid foundation for your pharmacovigilance compliance
A stable and well-documented PV system is the backbone of regulatory compliance and successful GVP inspections. I help you not only establish such a system but ensure it is practical, efficient, and sustainably effective. My focus lies on quality, structure, and implementability - tailored to your company’s size and operational needs.
Looking for GVP-compliant systems that are more than just documentation? I build PV quality systems that actually work in daily practice.
Inspection Readiness
Preparation and hands-on support for GVP inspections - including documentation reviews, mock interviews, and Q&A sessions.
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Deviation & Change Control
Implementation of structured, traceable processes to manage deviations and planned changes within your PV system.
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CAPA Management
CAPA processes based on root cause analysis - designed to ensure continuous improvement and audit/inspection readiness.
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GxP-Relevant PV Quality Processes
Design and optimization of quality-related processes relevant to pharmacovigilance, such as complaint handling, recall procedures, business continuity, archiving, and GxP-compliant documentation.
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My Services include:
Strategic & Operational
Local Contact Person for Germany
Being your official PV contact for local authorities - handling literature screening, case reports, and national requirements.
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Local Literature Screening
GVP-compliant screening of scientific and medical publications - tailored to the national requirements of the German market.
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Signal Screening
Monitoring PRAC publications for potential signals - aligned with EU regulatory expectations.
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Partner Reconciliation
Implementation of efficient reconciliation processes - ensuring consistent safety data exchange across all PV partners and internal departments.
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PV Training – Operational Focus
Conducting annual or role-based pharmacovigilance training for relevant personnel - covering responsibilities, reporting timelines, and basic GVP requirements.
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PV Activities & Operations
Operational support – efficient, compliant, and flexible
In addition to PV-strategic guidance, I support your daily pharmacovigilance activities with hands-on experience and a pragmatic mindset. Whether acting as Local Contact Person, conducting literature reviews, or handling reconciliation with partners - you get reliable, GVP-compliant support without expanding internal headcount.
Need flexible operational support? I can step in quickly - covering defined tasks or bridging resource gaps in your PV team.
My Services include:
PV Training – Role-based & Advanced Topics
Tailored training formats for onboarding local QPPVs/LCPs, role-specific PV responsibilities, or advanced GVP topics, delivered in a structured, compliant, and pragmatic manner.
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Strategic PV Consulting
Expert advice across all offered services - supporting system setup, process optimization, quality improvements, and external audits.
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International PV Compliance & Expansion
PV-Strategic support for companies expanding to or from the EU – aligning global PV systems with regional regulatory expectations.
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Partner Management & Onboarding
Coordination and oversight of PV partners - ensuring smooth onboarding, clear role distribution, and compliant collaboration.
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PV Projects & Interim Support
Support for short- or medium-term needs - from project-based assignments to temporary operational coverage. With proven experience across multiple GVP areas, I provide flexible, hands-on support that integrates seamlessly into your existing processes.
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PV Expertise & Consulting
Expertise & a strategic perspective
Whether you need targeted expertise or long-term support in building or improving your pharmacovigilance system - I advise with deep GVP knowledge and a focus on practical implementation. My guidance covers both internal systems and collaboration with external partners, helping you establish effective processes, mitigate risks, and ensure sustainable compliance.
Looking to strengthen your PV system or build expertise internally? Let’s define a PV strategy that fits your company’s setup and future plans.
My Services include:
Not sure what you need?
Whether you're looking for one-time support, interim help, or a long-term collaboration—I'm happy to explore how I can assist you best.
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