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.

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 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

Our expert staff