Pharmacovigilance Operations Manager Job at Amgen in Hyderabad | Jobslly

About the role & responsibilities
• Support configuration and optimization of global safety databases
• Perform UAT, system validation and safety data integrity checks
• Generate and review safety outputs for PSUR, DSUR, PADER, audits and inspections
• Configure reports, QBE searches and quality review processes
• Support study integrations and EDC–safety database mappings
• Drive automation and AI-enabled PV innovations
• Develop training, SOPs and support regulatory inspections

Qualification
• Master’s degree
• Bachelor’s degree with relevant PV experience accepted

Experience
• Pharmaceutical industry / health authority experience mandatory

Skills
• Argus / LifeSphere safety databases
• Aggregate safety reporting (PSUR, DSUR, PADER)
• PV analytics and data quality
• UAT and system validation
• Strong stakeholder communication

About the company
• Amgen is a global biopharmaceutical leader focused on innovation and patient safety