
Patient Safety and Quality Assurance Professional
2 days ago
About Us
Karo Healthcare is committed to empowering individuals to make informed health decisions. Our diverse portfolio across seven categories, including medical products, reflects our dedication to delivering innovative solutions that meet evolving healthcare needs.
We are seeking a skilled Pharmacovigilance Expert with Global Reach to join our team in Stockholm, Sweden.
- Develop and implement strategies for maintaining medicinal product safety profiles and risk-benefit evaluations.
- Manage activities within Safety Surveillance & Risk Management to ensure high-quality and timely completion.
- Collaborate with cross-functional teams to identify and mitigate potential safety risks associated with Karo products and third-party partners.
- Support EU & UK QPPV/deputy to maintain oversight of the PV system, focusing on Patient Safety surveillance activities.
- Analyze aggregate data, prepare reports like PBRER, PSUR, DSUR, Addendum to Clinical Overview, for Karo's medicinal products.
- Develop and implement risk management plans, ensuring compliance with regulatory requirements.
- Conduct signal validation and further signal assessment activities as applicable, contributing to Company Core Safety Information (CCSI) management.
- Present findings to the Safety Review Board and facilitate signal detection & validation activities.
- Cultivate a culture of safety awareness and continuous improvement within the organization.
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