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.

Tina Hjorth

Director, Pharmacovigilance Solutions

Tina holds a Master in Pharmacy degree and joined KLIFO in March 2017. Tina has been in the pharmaceutical industry for more than 25 years and has held positions as a Clinical Research Associate, Drug Development Scientist, Lead GCP Auditor and several managerial positions at different levels. Tina has extensive clinical experience and broad knowledge of the disciplines involved in the global execution of clinical trial programmes.

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