Business solution
KLIFO Pharmacovigilance Solutions meets the increasingly complex regulatory requirements for drug safety to ensure optimal compliance with international and national regulations and guidelines.
Our team of pharmacovigilance experts offers flexible and effective solutions to meet your individual project needs – from early clinical development to marketed product support.
Birgitte Sloth
VP
Birgitte joined KLIFO in February 2025, bringing with her more than two decades of experience in clinical science and drug development across both pharma and biotech.
Throughout her career, she has built extensive expertise in the scientific, strategic, and operational aspects of project and trial management, having held key roles as a Global Study Lead and Project Clinical Scientist.
Most recently, she was CSO, Drug Development at Pharma IT, following previous positions in Novo Nordisk and Novartis Institute of Biomedical Research.
Phone: +45 44 778 704
Email: birgitte.sloth@klifo.com
Expertise & therapy areas
Expertise:
KLIFO Pharmacovigilance Solutions offers seamless delivery on all the safety needs for your products by helping you with a range of pharmacovigilance services, including:
Support as your Pharmacovigilance department from pre-clinical stage to marketed products
- Strategic advice
- Preparation and review of pharmacovigilance documents (Development Safety Update Report, Periodic Safety Update Report, Risk Management Plan)
- Perform oversight activities for outsourced services on behalf of sponsor
- Hosting of global safety database
- Preparation of safety documents for regulatory filing
- Liaison with authorities
Pharmacovigilance support for your clinical trial
- Input to clinical trial protocol and informed consent form
- Hosting of safety database
- Serious adverse events: Case handling, medical assessment and reporting
- Coding of adverse events, medical history and medication
- Safety surveillance and signal detection
- Host and provide input for Safety Committee
Pharmacovigilance support for your marketed product
- Act as QPPV
- Pharmacovigilance system master files
- Preparation of Periodic Safety Update Report
- PV agreement negotiations with partners and subcontractors
- Local PV for Denmark, Sweden and Norway