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.
Short Description of Assignment:
This position functions as an expert in Pharmacovigilance (PV) Operations, ensuring end-to-end case processing from adverse event (AE) collection through submission. It sets standards for Individual Case Safety Report (ICSR) processing, including safety data collection from organized clinical activities and Clinical Study Start-up (CSS) for both interventional and non-interventional studies, expanded access programs, market research, and other research-related activities. The role operates both globally and regionally and supports senior levels with process management initiatives. The primary focus is to ensure routine safety data collection from clinical activities is fully executed and compliant with local and global requirements, with potential support for other ICSR and CRO monitoring tasks as needed.
Duties and Responsibilities:
- Support appropriate collection of AE data from local and global clinical start-up activities.
- Review clinical study protocols to ensure consistent safety requirements across related studies.
- Develop and maintain study-specific SAE Flow Plans and collaborate on associated documentation.
- Review proposals for clinical solicited activities (e.g., Expanded Access Programs) with Medical Safety and affiliates.
- Participate in contract reviews with third parties and Investigator Initiated Studies to define roles and responsibilities.
- Monitor clinical case workflows to ensure expected volumes and data capture.
- Serve as backup or Global Study Lead representing PV Operations in multidisciplinary study meetings.
- Handle complex clinical ICSR queries and develop training materials for clinical safety data management.
- Support process redesign, SOP ownership, CAPA management, and compliance initiatives within PV Operations.
- Act as SME during audits and inspections; escalate issues and collaborate cross-functionally with affiliates and partners.
Experience and Requirements:
- Bachelor’s degree in Life Sciences, Pharmacology, or Medicine with 5 to 7 years’ experience in PV; advanced degree is a plus.
- Strong understanding of European and international PV regulations.
- Experience in various PV operational areas, especially interventional and non-interventional trials; familiarity with electronic data capture and safety reporting preferred.
- Excellent computer skills and proficient English language abilities.
- Highly reliable with strong attention to detail and ability to meet deadlines with quality work.
- Positive attitude and excellent cross-cultural communication skills.
- Ability to work independently, identify issues, assess impact, and implement effective solutions.
