Louise Søgaard Nielsen Joins OZQA as Pharmacovigilance Consultant in Europe
- Mar 25
- 2 min read
Updated: Mar 26
OZQA is pleased to announce that Louise Søgaard Nielsen has joined the company as a pharmacovigilance consultant, further strengthening OZQA’s capabilities in supporting pharmaceutical and biotech companies with EU pharmacovigilance compliance.
With significant experience in pharmacovigilance operations and safety systems, Louise will support companies across Europe with the implementation and maintenance of GVP-compliant pharmacovigilance systems.
Strengthening Pharmacovigilance Consulting in Europe
Pharmacovigilance requirements in the European Union continue to evolve, and companies entering the EU market must establish structured safety systems that comply with EU pharmacovigilance legislation and EMA Good Pharmacovigilance Practice (GVP) guidelines.
As a pharmacovigilance consultant in Europe, Louise Søgaard Nielsen brings valuable experience supporting life science companies with practical pharmacovigilance processes and documentation.
Her expertise includes:
EU pharmacovigilance systems
Pharmacovigilance System Master Files (PSMF)
GVP-compliant SOP development
Safety case management and reporting
Pharmacovigilance inspection readiness
Her addition strengthens OZQA’s position as a specialised pharmacovigilance consulting partner for biotech and pharmaceutical companies operating in Europe.
Supporting Biotech and Pharmaceutical Companies
Many biotech and pharmaceutical companies require external support to establish and maintain compliant pharmacovigilance systems.
Through its pharmacovigilance consulting services, OZQA supports companies with:
Pharmacovigilance system setup
Development of PV SOPs and documentation
PSMF preparation and maintenance
GVP compliance support
Inspection and audit preparation
The focus is always on clear, practical and proportionate pharmacovigilance systems that meet EU regulatory expectations.
Expanding OZQA’s Pharmacovigilance Expertise
The addition of Louise Søgaard Nielsen reflects OZQA’s continued growth as a specialised consultancy supporting the European life science industry with quality systems and pharmacovigilance compliance.
With increasing regulatory expectations and a growing number of biotech companies entering the European market, the need for experienced pharmacovigilance consultants in Europe continues to expand.
We are very pleased to welcome Louise to the OZQA team.
