Overview: At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We're an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity.
Job Purpose: To facilitate operationalization of policies and procedures for pharmacovigilance oversight of Kyowa Kirin Patient Engagement Programs and other organized data collection and to assist with other global pharmacovigilance operations tasks. We operate a Hybrid working policy with 2 days in our office in Madrid and 3 days working from home.
Responsibilities: Collaborates with Commercial, Medical Affairs, and other relevant stakeholders to understand the scope of engagement activities to provide timely pharmacovigilance input prior to the launch of relevant programs.Build strong relationships with stakeholders who own/perform patient engagement activities to ensure adherence to pharmacovigilance requirements.Regularly review engagement activity data and liaise with stakeholders to ensure data related to these activities is complete, accurate, and of high quality.Collaborates with local pharmacovigilance responsible in all regions to ensure timely knowledge of new activities and ensure global oversight of pharmacovigilance activities required at a local level.Collaborate with the QPPV office for PSMF (pharmacovigilance system master file) and other pharmacovigilance related activities.Keep abreast of global pharmacovigilance regulations and guidelines and implement best practices.Collaborate on and contribute to innovative approaches to enable the continuous improvement of all processes.Collaborate with Pharmacovigilance Compliance to ensure CAPAs result in the efficient, compliant operational resolution of audit or inspection findings and deviations and pharmacovigilance operations are state of the art, efficient, compliant, and implemented globally throughout the global Kyowa Kirin pharmacovigilance organization. Qualifications: Bachelor's Degree required. Master's or healthcare/biosciences degree preferred.Experience with pharmacovigilance operational activities required to ensure efficiency and compliance across the product life cycle including both development and post-marketing activities.Previous experience with pharmacovigilance oversight of patient engagement activities is strongly preferred.
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