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.
Purpose of the function
This role supports the CSPV DSE SOP and Training Team Lead in the governance, maintenance and continuous improvement of Pharmacovigilance (PV) training activities and procedural documents within DSE and, where applicable, at global level. The position helps ensure that PV training processes and procedures are established and implemented in line with regulatory requirements, global standards and DSE expectations, while contributing to inspection readiness, compliance and continuous improvement.
Roles and Responsibilities
- Support the management, governance and continuous improvement of PV training processes, including role-based curricula, onboarding, continuous training activities and compliance monitoring across DSE.
- Coordinate with subject matter experts and stakeholders to develop, implement and maintain effective training content and training solutions, while following up on training gaps and compliance actions.
- Support the management, creation, revision, review and implementation of PV procedural documents in collaboration with relevant stakeholders, ensuring alignment with DSE, regional and global requirements.
- Provide guidance on procedural document processes and standards, and support harmonization, simplification and continuous improvement initiatives across SOP and training areas.
- Contribute to audit and inspection readiness, and support follow-up actions related to training, procedural documents, audits, inspections and quality events.
- Collaborate in global SOP and Training workstreams, represent DSE perspectives in cross-functional discussions and support implementation of globally agreed approaches within the region.
- Act as back-up support across Training and Procedural Document Management activities, and serve as delegate for defined SOP and Training activities when required
Additional Requirements
- Strong project coordination and steering skills, with the ability to manage multiple priorities in an international matrix environment.
- Excellent written and verbal communication skills in English, including strong intercultural communication and stakeholder management capabilities.
- Analytical, structured and solution-oriented mindset, with a high level of accuracy, reliability, flexibility and a proactive approach to continuous improvement.
Education & Experience
- University degree in a relevant discipline required.
- 5–8 years of professional experience in Pharmacovigilance or a related GxP-regulated environment.
- Broad knowledge of Pharmacovigilance processes and experience with procedural systems as part of a Quality Management System.
- Experience in training management, training compliance or training activities within a GxP environment.
- Good to excellent computer skills, including standard business applications and presentation tools.
- Experience working with cross-functional, regional and global stakeholders is highly desirable.
- Familiarity with audit and inspection readiness activities is preferred.
- Ability to work independently and collaboratively in a dynamic international environment.
