Pharmacovigilance Operations Manager

Amgen SA; Hyderabad; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Amgen seeks a Pharmacovigilance Operations Manager to oversee PV department activities, ensuring compliant handling of adverse event reports and timely regulatory submissions.

The role emphasizes cross-functional leadership, training development for case management, and oversight of vendor relationships and inspections to maintain inspection readiness.

Qualifications

• Master’s degree with 3+ years of related PV experience.
• Bachelor’s degree with 5+ years of related PV experience.
• Associate’s degree with 10+ years of related PV experience.
• High school diploma with 12+ years of related PV experience and team management experience.

Responsibilities

• Support ICSR processing to ensure high-quality cases and timely regulatory submissions.
• Provide vendors with resources and training to perform their role.
• Lead development and delivery of training materials for case management conventions.
• Manage multiple partner relationships for case management.
• Audit and external inspection support and readiness.

Skills

Regulatory knowledge

Project leadership

Safety systems

Audits/inspections

Education

Master's degree or higher

Bachelor's degree

Associate's degree

High school diploma or GED

Tools

Microsoft Office

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)

• Master’s degree and 3 years of directly related experienceOR
• Bachelor’s degree and 5 years of directly related experienceOR
• Associate’s 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