- Serves as the Research and Development Pharmacovigilance Quality Assurance leader in the respective region. Provides quality oversight of Pharmacovigilance in the respective region, ensuring that system audits are conducted, communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented.
- Serves as a strategic Good Pharmacovigilance Practice (GVP) resource to Takeda for its drug development activities, and takes a lead role for the preparation, conduct, and development of responses to health authority inspections of Takeda s development activities.
This position provides regional leadership and strategy in line with global strategic objectives. Collaborates with R&D Quality, Global Quality, R&D operational functions, and suppliers of outsourced services to ensure that Pharmacovigilance activities are conducted in compliance with GVP regulations, the International Conference on Harmonization (ICH) and Takeda requirements.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred.
- Routine demands of an office based environment.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel will be required.
- Requires approximately 50 % travel.
we are driven to improve people's lives
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.