High-quality Pharmacovigilance and Medical Information Services in the Nordics

Patient health and safe pharmacotherapy are our top priorities. Our highly skilled team of Pharmacovigilance experts specializes in handling drug safety responsibilities ranging from individual projects to entirely outsourced services in Finland, Sweden, Norway, and Denmark. We offer you expertise in managing EU QPPV and local QPPV tasks. If building an entire pharmacovigilance system is what you need, we are here for you.

Our job is to help our customers comply with the expectations and requirements set for Market Authorization Holders (MAH). Explore the variety of services that we offer in pharmacovigilance and medical information to make our customers’ lives easier.

Pharmacovigilance

Key pharmacovigilance tasks

• Processing ICSRs, medical assessment, MedDRA coding, submitting reports to the EudraVigilance database
• Monitoring social media and other websites
• Administrative duties related to pharmacovigilance, such as reconciliations, quality assurance of source data (e.g., in market research), compliance assurance and deviation reporting
• Global and local (Nordic) medical literature screening
• Pharmacovigilance training tailored to the needs of the customer

Pharmacovigilance systems

• Monitoring changes in legislation and competent authority regulations, and implementing the new requirements
• Designing and maintaining a pharmacovigilance system
• Preparing and maintaining a Pharmacovigilance System Master File (PSMF)
• Updating Risk Management Plans (RMP) and implementing Risk Minimisation Measures (RMM) as planned
• Monitoring the risk-benefit ratio, signal detection and signal management

Quality assurance

• Coaching customers for audits and inspections, assistance in meetings with authorities
• Mock audits for voluntary testing of the customer’s pharmacovigilance system

Medical Information

• Managing medical information functions for pharmaceutical and medical device companies, utilising our experience as the leading medical information centre in the Nordics
• Service is provided in Finnish, Danish, Norwegian, Swedish and English via phone, e-mail or chat
• Our unique, validated Case Management System and service-oriented experts ensure smooth communication with you and the patients.