Pharmacovigilance Operations Manager

Amgen Inc; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Amgen Inc. seeks a Pharmacovigilance Operations Manager to lead the pharmacovigilance department’s day-to-day operations, including adverse event handling, risk management, and safety communications.

The role ensures compliance with global safety regulations and guidelines across vendor management, inspections, and data exchange activities. The candidate will oversee ICSR processing quality, provide vendor resources, and drive training and QC initiatives while maintaining inspection readiness

Qualifications

• Masters degree with 3 years of directly related experience OR
• Bachelor's degree with 5 years of directly related experience OR
• Associates degree with 10 years of directly related experience OR
• High school diploma / GED with 12 years of related experience and prior team management

Responsibilities

• Support ICSR processing to ensure high-quality cases and timely regulatory submissions
• Provide vendors with resources and training for their role
• Support analysis and communication of QC results
• Lead development and delivery of training materials for case management conventions
• Support resolution of case-related queries
• Manage multiple business partner relationships for case management
• Support reviews of contract wording for case data exchange
• Monitor regulatory submission compliance and data exchange wording
• Assign tasks within Case Management to staff and vendors
• Support staff management within Case Management
• Escalate case processing issues
• Audit and external inspection support
• Maintain PV System Master File and inspection readiness
• Represent PV during Health Authority inspections and internal audits
• Perform other duties per SOPs or supervisor guidance
• Lead development and delivery of convention-related training material
• Support training of local office staff
• Perform US case follow-up activities
• BP reconciliation as required by safety agreement
• Generate and distribute QC performance metrics
• Support training and onboarding of vendors
• Oversee data exchange contract wording reviews
• Support regulator inspections and vendor audits/inspections
• Relay metrics to vendors and monitor performance
• Generate, communicate, and archive QC findings

Skills

Pharmacovigilance

Regulatory knowledge

Project leadership

Safety systems

Inspections

MS Office

Education

Master's degree (related field)

Bachelor's degree

Associates degree

High school diploma

Related leadership/management experience

Tools

Microsoft Office Suite

Safety systems software

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 audits of CAPAs and other actions/recommendations for ICSR quality related measures
• Perform case review as required
• Lead development and delivery of convention‑related training material
• Support training of local office staff
• Perform US case follow up activities
• Perform BP reconciliation as required by safety agreement
• Generate and distribute performance metrics (submission compliance, volumes, turnaround times)
• Support reviews of contract wording for case related data exchange
• Support regulatory inspection and support for vendor audits/inspections
• Oversee performance monitoring and relay metrics to vendors
• Support analysis of QC trends including actions/recommendations
• Generate, communicate, and archive report of QC findings

Knowledge and Skills

• Understanding of global regulatory requirements for pharmacovigilance
• Project leadership experience
• Competence in safety systems
• Experience in supporting inspections or internal audits
• Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook

Education & Experience (Basic)

• Masters degree and 3 years of directly related experienceOR
• Bachelors degree and 5 years of directly related experienceOR
• Associates degree and 10 years of directly related experienceOR
• High school diploma / GED and 12 years of directly related experience, AND
• Previous experience directly managing teams, projects, programs or directing the allocation of resources