Pharmacovigilance

Is the management of daily pharmacovigilance activities too resource-intensive? Do you occasionally need special expertise?

We offer easy and efficient access to pharmacovigilance services, including up-to-date information on pharmacovigilance requirements and other topical issues. Our team helps ensure you stay on course at all times.

Pharmacovigilance activities provide the foundation for the use of medicinal products and an element of risk management.

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Examples of our services:

  • Serving as pharmacovigilance specialists and/or qualified persons for pharmacovigilance (QPPV)
  • Medical assessment and MedDRA classification of adverse reactions, electronic reporting of adverse reactions to the EudraVigilance system
  • Global medical literature monitoring, local medical literature monitoring in the Nordic region
  • Monitoring of risk-benefit ratios, signal detection and management
  • Preparation and maintenance of Pharmacovigilance System Master Files (PSMF)
  • Preparation of risk management plans (RMP) and implementation of measures
  • Preparation of Periodic Safety Update Reports (PSUR)
  • Medical support
  • Submission of medicinal product information (Article 57 and ISO IDMP) to the EudraVigilance database, including real-time maintenance of information
  • Monitoring of regulatory guidelines and requirements.

DRA’s consultants are really competent and knowledgeable.

You provide just the kind of expertise we need. Your experts complete their tasks on time and manage assignments from start to finish.

Our team safeguards your company’s pharmacovigilance activities. We will ensure that your drug safety monitoring, reporting and safety risk management activities are in compliance with requirements. Accuracy, precision and tight schedules are second nature to us.

We provide you with added value, because we act as if we were part of your company.

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We will monitor the safety of your products with a vigilant eye and take immediate action should the occasion arise, giving you peace of mind.

Order tailored pharmacovigilance training.

DRA Academy