Global Patient Safety Surveillance Expert

16 hours ago


Stockholm, Stockholm, Sweden Karo Healthcare Full time

Company Overview

Karo Healthcare is a dynamic and rapidly growing company that empowers people to make intelligent health decisions. Our portfolio spans across seven categories, including medical products, with over 80 brands sold in approximately 90 countries. We believe in driving growth through a combination of organic expansion and strategic acquisitions.

Our commitment to innovation and customer satisfaction has led us to become a leading player in the consumer health industry in Europe. With a strong presence in the market, we continue to expand our reach and improve our services.

Job Description

We are currently seeking a skilled Global Patient Safety Surveillance Specialist to join our team at our headquarter office in Stockholm, Sweden. This role will play a crucial part in ensuring the safety and efficacy of our medicinal products throughout their lifecycle.

  • Develop and maintain a thorough understanding of medicinal product safety profiles and risk-benefit evaluations.
  • Ensure high-quality activities are completed on time within Safety Surveillance & Risk Management.
  • Support EU & UK QPPV/deputy to maintain oversight of the PV system, particularly for Patient Safety surveillance activities.
  • Provide aggregate data, write, and review reports, such as PBRER, PSUR, DSUR, Addendum to Clinical overview, for Karo's medicinal products.
  • Contribute to the development and maintenance of Risk Management Plans (RMPs) and risk minimisation measures.
  • Perform signal validation and further signal assessment activities as applicable, and contribute to the Company Core Safety Information (CCSI) management.
  • Identify and communicate potential safety issues within the Surveillance Team.
  • Contribute to the continuous improvement of KARO's systems related to surveillance activities.

Required Skills and Qualifications

To succeed in this role, you will require:

  • A Master's degree in Pharmacy, Medicine, or a related life science field.
  • At least 3 years of Pharmacovigilance experience in the pharmaceutical industry.
  • Experience in Aggregated Reports and Signal Management.
  • Fluent oral and written communication skills in English.
  • Expertise in MS Office applications, including Word, Excel, and PowerPoint.
  • Experience with Veeva Vault Safety.
  • Knowledge of Pharmacovigilance Guidelines and Regulations.

Benefits

As a member of our team, you can expect:

  • A dynamic and multitasking business environment.
  • Flexible scheduling options, including hybrid work models.
  • Opportunities for growth and development in a fast-paced industry.
  • Responsibility for challenging projects with direct impact on customers and the industry.
  • A very positive work environment in an international and motivated team.


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