Career Category
Safety
Job Description
The Pharmacovigilance Operations Manager at Amgen oversees the operations of the pharmacovigilance department, including the handling of adverse event reports, risk management, and safety communication. They ensure compliance with global safety regulations and guidelines.
Job Summary
Responsible for:
Support ICSR processing to ensure high-quality cases in a timely manner to meet all worldwide regulatory authority requirements
Provide vendors with resources and training to perform their role
Support the analysis and communication of case QC results
Lead development and delivery of training materials for case management conventions
Support resolution of case related specific queries
Management of multiple business partner relationships for case management
Support reviews of contract wording for case related data exchange
Monitoring compliance regarding regulatory submissions and/or contractual wording for data exchange
Assign tasks within Case Management to direct and indirect reports
Support management of staff within Case Management




Escalation of case processing issues
Audit & external inspection support
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Key Activities
Day-to-day vendor management issues
Interact with other local safety offices
Ensure case processing timelines for AE intake, triage and submission are met
Assess workload to assist in resource management
Support on-boarding and on-going training of vendors
Attend management meetings with vendors
Support analysis of QC trends
Support generating, communicating, and archiving of reports of QC findings
Support a

📌 Pharmacovigilance Operations Manager (Hyderabad)
🏢 AMGEN
📍 Hyderabad