Business solution
KLIFO Pharmacovigilance Solutions meets the increasingly complex regulatory requirements of drug safety to ensure optimal compliance with international and national regulations and guidelines. Our team of certified pharmacovigilance experts offers flexible and effective solutions to meet your individual project needs – from early clinical development to marketed product support.
Randi Rahbæk
Senior Director
Randi holds a MSc in Pharmacy and joined KLIFO in January 2021. She has more than 20 years of experience within people leadership, drug development and clinical operations excellence and has been with large, mid-sized and small pharma companies as Director for Trial Operations and Business Support.
During her career, Randi has been operational responsible for planning and execution of global clinical development programs from early stage to the post-approval phase.
Direct/mobile: + 45 44 778 704
Email: moc.ofilk@keabhar.idnar
Expertise &
therapy areas
Expertise
KLIFO Pharmacovigilance Solutions offers seamless delivery on all the safety needs for your marketed products by helping you with a range of pharmacovigilance services, including:
- Safety management in relation to clinical trials
- Full PV services with our PV system
- QPPV for clients
- Strategic advice and Liaison with authorities
- Preparation and review of pharmacovigilance documents:
- CCSIs
- PSURs, DSURs and RMPs
- Data entry and medical assessment of individual case safety reports from various sources, including:
- Writing of safety narratives and company comments
- Coding of adverse events, medical history and concomitant medication
- Assessment of seriousness, listedness and causality
- Pharmacovigilance system master files
- PV agreement negotiations with partners and subcontractors
- Pharmacovigilance procedures management
- Medical devices:
- Device vigilance
