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.

Cathrina Karup

Director

Cathrina holds a Doctor of Medicine degree and joined KLIFO in January 2018. She has been working with Pharmacovigilance for more than 12 years across a range of therapeutic areas and with products in all phases of clinical development as well as post-marketing.

Direct/mobile: +45 44 222 930

Email: cathrina.karup@klifo.com

Expertise &
therapy areas


Expertise:

KLIFO Pharmacovigilance Solutions offers seamless delivery on all the safety needs for your marketed products by helping you with a rane 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

Our expert staff


Hanne Fredshavn

Pharmacovigilance Associate

Mette Seiffert

Pharmacovigilance Associate

Flemming Kjær Jørgensen

Senior Pharmacovigilance Specialist

Flemming holds a Master of Pharmacy degree and joined KLIFO in September 2015. He has more than 10 years of pharmacovigilance experience from both private consulting and as an insourced consultant in big pharma and biotech companies. Flemming has extensive experience writing pharmacovigilance documents such as PSURs, DSURs, signal reports and RMPs.

Peter Eriksen

Senior Pharmacovigilance Specialist

Peter holds an MSc in Pharmacovigilance from Hertfordshire and is a CCRN. He joined KLIFO in 2017.
Peter has been working at hospitals for 10 years and with pharmacovigilance in the pharmaceutical industry for 16 years. His main focus areas are setup of and conducting clinical trials, event adjudication, DSMBs, SOPs and signal detection.