Patient Safety Associate I

About the role

We are seeking a detail-oriented Patient Safety Associate I to join our team in on-site capacity, based in Mohali. As a Patient Safety Associate, you will support pharmacovigilance and drug safety operations across clinical trials and post-marketing activities.

What you'll do

• Process Individual Case Safety Reports (ICSRs) from various sources, including data entry
• Perform literature searches and reviews to identify potential adverse drug reactions and safety signals
• Support safety submissions to regulatory authorities, ethics committees, and other stakeholders within required timelines
• Assist in signal detection, compliance tracking, and the generation of safety metrics
• Ensure the accuracy, completeness, and regulatory compliance of safety data and documentation

What you need

• Pharmacovigilance
• Medical coding
• Clinical research
• Communication
• Documentation
• Reconciliation
• M.Pharm or BDS

Good to have

• SOP writing