We have long experience from the pharmaceutical industry, government inspections and expertise in pharmacovigilance legislation. We perform audits of marketing authorisation holder (MAH), partner companies and service providers to identify GAPS in the pharmacovigilance system.
With our expertise, we ensure fit for purpose pharmacovigilance systems, compliant with existing pharmacovigilance regulations.
Our Pharmacovigilance team
Katarina Andersson and Sari Öbrink bring 30+ years of experience from the area of post marketing pharmacovigilance from both the Swedish Medical Products Agency and the pharmaceutical industry. They provide valuable insight in achieving efficient and well-functioning pharmacovigilance systems in compliance with the regulations.
Katarina joined the RegSmart team four years ago. Since then, she has performed several full scope and targeted audits of Market Autorisation Holders and Pharmacovigilance vendors within Europe and US, held long term interim assignments, such as Director QA/GCP and Senior Drug Safety Manager/deputy Quality Person Responsible for Pharmacovigilance at small and mid-sized pharmaceutical companies, as well as trained personnel for Inspection readiness.
Prior to joining RegSmart, Katarina held the position as Pharmacovigilance inspector at the Swedish Medical Products Agency for 12 years, the last six years as Head of the GVP/GCP group of inspectors.
“After many years as pharmaceutical inspector pharmacovigilance, I find it meaningful to use my experience to support pharmaceutical companies in building and developing their PV-systems in compliance with the regulations and make sure they are inspection ready“ says Katarina.
Sari joined the team this spring, and brings a broad background as pharmacovigilance consultant, with the last seven years from roles as Qualified Person for Pharmacovigilance and deputy QPPV for local pharmaceutical companies, Responsible Person for wholesale for local distributors, as well as safety manager in clinical trials and a GVP and GDP auditor. The last five years, she also held the position as Head of PV and GDP.
Sari has audited Market Authorised Holders Pharmacovigilance system and their Pharmacovigilance vendors and distributor´s quality management system and their suppliers in European countries.
“I am looking forward to supporting customers with creating a pharmacovigilance system to ensure compliance with the pharmacovigilance regulation and activities to bring safe medicines to patients” says Sari.
Most welcome for a first contact to discuss your needs in the Pharmacovigilance area!
Read more about our services on https://regsmart.se/pharmacovigilance/ or contact info@regsmart.se