Medicinal Product Safety Analyst

11 hours ago


Stockholm, Stockholm, Sweden Karo Healthcare Full time
Job Description

The Global Patient Safety Surveillance Specialist will play a critical role in ensuring the safe use of our medicinal products. Key responsibilities include:

  • Ensuring high-quality risk-benefit evaluations during the lifecycle of our products;
  • Coordinating activities within Safety Surveillance & Risk Management to maintain high-quality standards;
  • Supporting EU & UK QPPV/deputy to enable them to oversee the PV system, particularly for Patient Safety surveillance activities;
  • Providing aggregate data and contributing to clinical overviews, PBRERs, PSURs, DSURs, and Addendums for Karo's medicinal products;
  • Conducting signal validation and further signal assessment activities as applicable, and contributing to CCSI management;
  • Bringing suspected safety concerns to the Safety Review Board and presenting signal detection & validation activities;
  • Contributing to continuously improving safety signal management processes to reflect regulatory trends and guidelines;
  • Identifying and communicating potential safety issues within the Surveillance Team;
  • Providing input to the continuous improvement of KARO's systems related to surveillance activities;
  • Performing PV intelligence activities according to Karo processes.

This role requires strong analytical skills, attention to detail, and effective communication. If you have experience in Pharmacovigilance and are passionate about patient safety, please apply



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