
Global Patient Safety Risk Manager
3 days ago
About Us
Karo Healthcare is a dynamic and growing company dedicated to making informed healthcare choices. Our portfolio spans seven categories, including medical products, with over 80 brands sold in about 90 countries. We empower people to make intelligent health decisions, driving our growth strategy through organic expansion and M&A.
As a leader in the industry, we're looking for a skilled Global Patient Safety Risk Manager to join our headquarters in Stockholm, Sweden.
- Ensure medicinal product safety profiles and risk-benefit evaluations are maintained throughout their lifecycle.
- Maintain high-quality and timely completion of activities within Safety Surveillance & Risk Management.
- Oversee all activities under own responsibility for Karo products and third-party partners with whom we hold Safety Data Exchange Agreements (SDEA)/Pharmacovigilance Agreement (PVA).
- Support EU & UK QPPV/deputy to enable the QPPV to maintain oversight of the PV system, particularly for Patient Safety surveillance activities.
- Provide aggregate data, write and review reports like PBRER, PSUR, DSUR, Addendum to Clinical Overview, for Karo's medicinal products.
- Contribute to writing, reviewing, or contributing to Risk Management Plans (RMPs) and any risk minimization measures.
- Perform signal validation and further signal assessment activities as applicable, and contribute to Company Core Safety Information (CCSI) management.
- Present suspected safety concerns to the Safety Review Board and signal detection & validation activities.
- Contribute to continuous improvement of KARO's systems related to surveillance activities.
- Identify and communicate potential safety issues in the Surveillance Team.
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