Responsible for leading and overseeing local pharmacovigilance activities, including adverse event case processing, safety reporting to Health Authorities, customer complaint handling, regulatory compliance, data quality, and stakeholder collaboration across clinical development and post-marketing activities.
The brain is remarkably resilient, but the details of how adaptive adjustments play out in the adult brain remain poorly understood. Our studies reveal that the homeostatic form and function of mature neural cells are maintained through active suppression of alternative structural and functional possibilities.
Preferred certifications include pharmacovigilance or drug safety training from recognized industry bodies such as DIA or similar professional organizations.
The Lead is expected to have extensive experience and provide thought leadership in Data Governance and Compliance, as well as on how the regulatory and pharmacovigilance (safety) systems, processes, and data interact and interface with other aspects of the Astellas information ecosystem.
Schizophrenia is a complex psychiatric disease for which the cellular and molecular mechanisms that drive disease onset and progression remain poorly understood.
PhD in Science Salary will be commensurate to qualifications and research experience. This position is available in the lab of Dr. Bhavana Muralidharan, who studies brain development in health and disease. BRIC-inStem
Excellent negotiation skills with external and internal clients. Ability to make decisions independently and proactively. Excellent organizational, planning skills
Lead the Quality Assurance and Quality Control operations across all manufacturing units at HLL-KFB, ensuring compliance with cGMP, ISO13485, WHO-GMP and other regulatory standards