
About the Role
The Mid-Level Drug Safety Associate plays a critical role in managing independent case processing activities while ensuring quality and regulatory compliance across global PV operations.
Key Responsibilities
Independently manage case intake, triage, and end-to-end case processing
Perform QC reviews on junior team members’ cases
Ensure adherence to global regulatory timelines (US FDA, EMA, MHRA, etc.)
Support process improvement initiatives and SOP updates
Collaborate with cross-functional global safety teams
Requirements
5–10 years of experience in Drug Safety / Pharmacovigilance
Strong expertise in ICSR processing and QC activities
Proficiency in safety databases and coding conventions
Good understanding of global PV regulations and compliance standards
Ability to mentor junior team members