Executive Vigilance Assessor, Vigilance Assessment - Human Products Monitoring

Closing date for applications: 17/08/2022

Role summary

Reporting to the Vigilance Assessment Manager the role of the Executive Vigilance Assessor is to proactively participate in the management, development and operation of the Vigilance Assessment section.

The Executive Vigilance Assessor will achieve this through the following key aspects:

  • Line management of department personnel and assisting the Vigilance Assessment Manager in defining objectives, settings targets, coordinating activities, agreeing priorities, developing team members and maintaining effective communication lines.

  • Coordinating a strategic scientific quality assurance approach to vigilance assessment activities, supporting an excellence in pharmacovigilance model across the section.

  • Acting as a subject matter expert, contributing to cross departmental and organisational initiatives, as well as representing the HPRA on technical matters relevant to the remit of vigilance assessment.

  • Leading assessment of Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP), Post Marketing Commitments (PMCs), Post-Authorisation Safety Studies (PASS), referral procedures, PRAC-led variations and risk minimisation plans.

  • Performing signal management and evaluation of new and emerging data from a variety of data streams.

  • Ensuring that the required scientific expertise, standards, policies and practices are in place for the assessment of all application types received and ensuring robust scientific decisions underpin the advice, recommendations, conclusions as well as any actions arising from post-market surveillance activities.

  • Deputise for colleagues and to ensure appropriate cover within the Vigilance Assessment section as required.

  • Other duties as may be required with regard to the post marketing regulation of human medicines.

 

For more information please refer to the role profile below. Applications should be submitted via the HPRA Recruitment Portal.



Role Profile                  Application form

 

 



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