Pharmacovigilance Expert

4 days ago


Stockholm, Stockholm, Sweden Karo Healthcare Full time
About the Role

This is an exciting opportunity to join Karo Healthcare's Pharmacovigilance team as a Global Patient Safety Surveillance Specialist.

You will be responsible for maintaining an overview of medicinal product safety profiles and risk-benefit evaluations throughout the product lifecycle.

Main Responsibilities:

  • Evaluate all activities under your responsibility to ensure they meet high-quality and timely standards within Safety Surveillance & Risk Management.
  • Support the EU & UK QPPV/deputy in maintaining oversight of the PV system, particularly for Patient Safety surveillance activities.
  • Provide aggregate data and create reports, such as PBRER, PSUR, DSUR, Addendum to Clinical Overview, for Karo's medicinal products.
  • Develop, review, or contribute to Risk Management Plans (RMPs) and risk minimization measures.

Requirements:

  • Bachelor's or Master's degree in Pharmacy, Medicine, or Life Sciences.
  • Minimum three years of Pharmacovigilance experience in the pharmaceutical industry.
  • Experience with Aggregated Reports and Signal Management.
  • Fluent oral and written English skills.


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