Overview
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to be an innovative global healthcare company contributing to the sustainable development of society, we are shaping a healthier, more hopeful future for patients, their families, and society. For our Daiichi Sankyo European Headquarters (in Munich), we are looking for a Senior Director (m/f/d) DSE Pharmacovigilance Operations (PVOps).
Responsibilities
* Leads the PV Operations team at DSE which oversees individual case safety reports from pre- and post-marketing sources, ensuring the appropriate collection and processing of safety reports in compliance with regulatory guidelines and internal standards.
* Develops and drives the strategy for the PV Operations function at regional and global levels, promotes internal process compliance, excellence and efficiency, and proposes process improvements and redesigns.
* Reports to the Executive Director PV Systems and Operations for DSE and to Global PV Operations Sub-Function Leads for ICSR/CRO Management and CSS, respectively.
* Collaborates with PV Systems sub-functions (Database Management and Analytics, Partner and Affiliate Management, PV Quality Management) to ensure appropriate collection of safety information globally and at the local affiliate level; oversees CRO case processing and ensures compliance targets for case reporting and quality.
* Oversees operational setup of safety data collection from pre- and post-marketing activities (clinical studies, Managed Access Programmes, Patient Support Programmes, market research, and other data sources) and ensures adverse event data is maintained in regulatory compliance.
* Reviews protocols/study observational plans, develops adverse event flow plans, configures databases, and develops eCRF/eDC and reconciliation processes; inputs to revision of procedural documents and aligns regionally with the Global CSS strategy.
* Acts as a key contributor to process improvements to meet regulatory demands and enhance efficiency; develops and tracks CAPAs related to PV operations findings and ensures communication and escalation of compliance issues to leadership and stakeholders for continuous improvement.
* Manages DSE PV Operations Team leaders to ensure ICSR handling and clinical study start-up activities are compliant with regulatory requirements and global standards; ensures adequate resourcing and handles line management aspects including hiring and compensation; may lead specific teams within global PV Operations in a matrix environment.
* Has overall line management responsibility for the DSE PV Operations Team, including hiring, compensation, and personnel management decisions; may participate in matrix management across regions in line with Global PV Operations
Personal Skills And Professional Experience
* Medical doctor, pharmacist, or Bachelor’s degree, preferably in healthcare or life sciences
* Sufficient expertise in local, European and international regulatory and pharmacovigilance requirements
* Proven pharmacovigilance experience across investigational and marketed products, with solid management experience
* Situational leadership that develops team capabilities and promotes growth
* Experience developing performance expectations and implementing process improvements
* Ability to develop and execute complex functional strategic plans and prioritize tasks
* Analytical problem-solving skills with the ability to identify issues, assess causes, balance risks, and implement solutions
* Effective leadership and subject matter expert contributions to PV operational processes
* Strong communication within functional teams and across regions/global functions
* Ability to ensure timely delivery of internal and external deliverables and promote operational excellence
* Excellent English skills
Why work with us?
Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. You will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
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