Career Category

Job Description

Group Purpose

The Office of the Qualified Person for Pharmacovigilance (QPPV) ensures the establishment and maintenance of a quality pharmacovigilance system for Amgen

Job Summary

This role is responsible for providing scientific support to the QPPV Office to facilitate oversight of the Amgen PV system. The role reports into the EU QPPV.

Ensures back-up procedures are initiated in the EU and  followed if contact with EU QPPV is requested by the agency or relevant competent authority.

Key Activities

• During any periods of absence by the EU QPPV, initiate from the EU any steps to ensure all activities are triaged to appropriate Amgen staff to action upon any request from the agency or relevant competent authorities.
• Review and comment on EU RMPs, periodic/aggregate reports and other relevant documents for scientific oversight and compliance to applicable regulations and law
• Manage PASS process including maintenance of PASS tracker
• Determines post-authorization safety study (PASS) status in partnership with the Global Safety Officer (GSO)
• Provides guidance for the set-up of a local PSMF for countries in emerging markets
• Collaborate with the PSMF Compliance and Oversight Lead, on the quarterly update and maintenance of the PSMF and act as back-up if needed
• Coordinate the update of Annex H2 by the GSOs
• Participate in local or global project teams as a subject matter expert in EU regulation and compliance
• As required, represent EU QPPV office internally and externally
• Author, contribute to, and review SOPs, MANs and other controlled documents relevant to the EU QPPV Office.
• Escalate potential product safety issues or concerns to EU QPPV for input and resolution
• As appropriate, review and perform impact analysis (also solution proposals) on Health Authority proposals for changes in pharmacovigilance regulations and guidelines
• Provide training on aspects of EU legislation as required
• Contribute to regular EU QPPV office meetings to ensure information on safety issues, regulatory safety issues, signals undergoing evaluation and other aspects of the PV system is efficiently communicated across the EU QPPV Office
• Undertake activities delegated by the EU 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 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
• Provides operational business support to the EU QPPV Office. Lead initiatives/process improvement opportunities as designated by EU QPPV
• Partner with EU QPPV Management team to drive and implement strategy, goals and initiatives
• Collaborates cross-functionally with Local Safety Officers and other Amgen departmental interfaces
• Proactively identify and resolve upcoming issues within the EU QPPV office and work with stakeholders as needed