About the Role
The Senior Drug Safety Associate provides subject-matter expertise in pharmacovigilance operations, overseeing complex case management, quality oversight, and process excellence.
Key Responsibilities
Lead and oversee end-to-end safety case processing and QC
Review complex and high-risk cases for regulatory compliance
Provide mentoring, training, and guidance to PV teams
Support audits, inspections, and client interactions
Contribute to SOP development, process optimization, and best practices
Requirements
10+ years of progressive experience in Drug Safety / Pharmacovigilance
Strong leadership in safety case processing and quality oversight
Deep understanding of global PV regulations and inspection readiness
Excellent communication and stakeholder management skills
Experience working with global clients and CRO environments