Patient Safety Associate II / Patient Safety Specialist

About the role

We are seeking a Patient Safety Associate II/Specialist to join our Patient Safety Operations team in a Temporary assignment (Contract role for 9 months) for on-site capacity. As a Patient Safety Associate II/Specialist, you will support global pharmacovigilance activities that advance new treatments for patients.

What you'll do

• Monitor, process, and assess incoming safety reports from various sources
• Execute safety case processing workflows including MedDRA coding, causality assessment, expectedness determination, and preparation of case documentation and narratives
• Execute ICSR and periodic report submissions to regulatory authorities, maintaining compliance with global reporting timelines and regulatory requirements
• Implement literature search strategies, screen publications for adverse drug reactions, identify potential safety signals
• Support communication and coordination between global safety operations and local affiliates

What you need

• 2–5 yrs of experience
• Reporting
• Pharmacovigilance
• Clinical research
• Data analysis
• Microbiology
• SOP writing
• Any graduate

Good to have

• Regulatory affairs
• Reconciliation