Be responsible for the development and implementation of China Clinical Safety strategy for assigned projects and products throughout all stages of development, and ensure CN alignment for Project Specific Safety Requirements (PSSR)
Job Summary
Be responsible for the development and implementation of China Clinical Safety strategy for assigned projects and products throughout all stages of development, and ensure CN alignment for Project Specific Safety Requirements (PSSR).
Oversight of the full disease area product portfolio, and link with local management and key stakeholders.
Accountable for mentoring, performance evaluation and career development of the team members.
Matching Summary
Be responsible for the development and implementation of China Clinical Safety strategy for assigned projects and products throughout all stages of development, and ensure CN alignment for Project Specific Safety Requirements (PSSR).
Skills & Requirements
Must-have
China Clinical Safety strategy
development of LRMPs
medical review of ICSR
signal detection and evaluation
pharmacovigilance and Patient Benefit risk assessment
drug development experience
Nice-to-have
inclusive and diverse team
harnessing industry-leading skills
collaboration with key stakeholders
Key Requirements
At least 10 years of Drug Development/Patient Safety experience
Strong people management and leadership capabilities
Adequate understanding of China and global regulations