Daiichi Sankyo Europe
Senior Manager PV Quality Management(m/w/x)
Vollzeit
Senior
Keine Angabe
München
DA
Daiichi Sankyo Europe1 Monat
Senior Director DSE Pharmacovigilance Operations (PVOps)(m/w/x)
Vollzeit
Senior
Keine Angabe
München
Nejo KI-Zusammenfassung
In this role, you will lead the DSE Pharmacovigilance Operations team, ensuring compliance in safety report management while driving process improvements and collaborating with various sub-functions to enhance operational efficiency.
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Anforderungen
- •Medical doctor, pharmacist, or Bachelor's degree in healthcare or life sciences
- •Expertise in local, European, and international regulatory and pharmacovigilance requirements
- •Profound work experience in pharmacovigilance, including investigational and marketed products
- •Situational leadership and team development skills
- •Performance expectation development and supervision skills
- •Complex functional strategic planning and task prioritization
- •Ability to identify issues and provide resolutions
- •Effective leadership and subject matter expertise in PV operational processes
- •Effective communication within functional teams
- •Execution of internal and external deliverables on time
- •Excellent English skills
Bachelor-Abschluss
Berufserfahrung
ca. 4 – 6 Jahre
Deine Aufgaben
- •Lead the PV Operations team at DSE
- •Oversee individual case safety reports from pre- and post-marketing sources
- •Ensure compliance with regulatory guidelines and internal standards
- •Develop and drive the strategy for PV Operations at regional and global levels
- •Promote internal process compliance, excellence, and efficiency
- •Collaborate with PV Systems sub-functions for safety information collection
- •Monitor the system for collection, processing, and reporting of ICSRs
- •Ensure ICSR report intake and case processing meet compliance targets
- •Manage non-conformances related to ICSR/CRO management
- •Provide direction to the PV Operations Standards Team
- •Oversee safety data collection from clinical activities
- •Facilitate communication for clinical activity design and setup
- •Ensure compliance in adverse event collection and reporting
- •Identify areas for process improvement and implement changes
- •Track implementation of corrective/preventive actions
- •Manage the DSE PV Operations Team leaders
- •Ensure adequate resourcing and personnel management decisions
- •Lead specific teams within global PV Operations in a matrix setting
Sprachen
Englisch – verhandlungssicher
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