Leading a global team, the full-time remote Global Safety Director will be responsible for the development and oversight of Pharmacovigilance Operations strategy for the production and submission of periodic aggregate safety reports (PASRs), ensuring compliance with global regulatory requirements and internal policies.
Key Responsibilities:
Provide global leadership for the PASR team to ensure regulatory compliance in the production and submission of all reports
Develop and maintain the Global Periodic Reports Schedule, Standards, and Procedures
Act as a liaison between external vendors, Global Patient Safety, and cross-functional teams in the creation of PASRs
Required Qualifications:
Doctorate degree and 4 years of Global Safety experience, or Master's degree and 8 years, or Bachelor's degree and 10 years of relevant experience
At least 4 years of experience directly managing people or leading teams and projects
Experience in regulatory compliance and safety reporting processes
Demonstrated ability to manage cross-functional collaborations effectively
Familiarity with Health Authority Inspection and Internal Process Audits