Pharmacovigilance Operations Manager

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 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 experience OR

Bachelor’s degree and 5 years of directly related experience OR

Associate’s degree and 10 years of directly related experience OR

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

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