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About the Role
The Executive – Pharmacovigilance & Drug Safety is responsible for managing signal detection, evaluation, documentation and communication activities to ensure patient safety and regulatory compliance.
Key Responsibilities
Prepare and maintain signal schedules as per SOPs
Identify, analyze and evaluate safety signals from multiple data sources
Assess benefit–risk impact and potential label change requirements
Prepare product-specific ADR sheets
Author Drug Safety Reports for validated signals
Communicate signal findings to internal stakeholders
Support cross-functional initiatives to enhance pharmacovigilance capabilities
Stay updated with global regulatory guidelines related to signal management
Ensure compliance with SOPs, timelines and quality standards
Assist in development and revision of SOPs, templates and work instructions
Deliver signal management training to internal teams
Qualification
Pharm D / Doctor of Pharmacy
Skills and Knowledge
Signal detection and evaluation
Pharmacovigilance regulations
Drug safety reporting
Documentation management
Strong analytical and communication skills
About the Company
Amneal is a global pharmaceutical company committed to patient safety, regulatory excellence, and a diverse and inclusive workplace.