Job Description
Leads the execution and continuous improvement of global pharmacovigilance operations to ensure compliant, efficient, and high-quality safety data management across clinical and post-marketing programs. Drives cross-functional coordination and vendor oversight to support timely adverse event reporting, inspection readiness, and regulatory compliance. Contributes to the enhancement of pharmacovigilance processes and systems to support program advancement and global expansion.
Key Accountabilities / Core Job Responsibilities
- Oversee global pharmacovigilance operations for assigned clinical programs
- Ensure compliant safety case intake, processing, reporting, and reconciliation across all sources (including clinical studies and post-marketing sources)
- Oversee safety case management activities to ensure adherence to global regulatory requirements, company procedures, and reporting timelines
- Manage pharmacovigilance vendors and external p...