Pharmacovigilance Manager, Pharmacovigilance - Human Products Monitoring (HPM)

Closing date for applications: 11/01/2021

ROLE SUMMARY

 

The Human Products Monitoring department of the HPRA is responsible for post-market surveillance activities and operating a system of pharmacovigilance to fulfil tasks associated with monitoring the safety of authorised health products, including medicines and vaccines, and for detecting any change to their risk-benefit balance. The department also has a number of vigilance responsibilities associated with investigational medicinal products, blood/tissues and cells and organs (BTO). 

 

The HPM department is comprised of two sections. The PV manager, will report to the Director of Human Products Monitoring, and will direct, support and lead the PV section to achieve required levels of performance, with responsibility for the following;

 

  • Technical leadership of the PV section, comprised of approximately 17 healthcare, scientific and administrative personnel.
  • Technical leadership and oversight of the national adverse reaction reporting system for medicines (including vaccines), from collection, receipt, triage, assessment, processing and regulatory reporting, as appropriate.
  • Overseeing the assessment of Suspected Unexpected Serious Adverse Reaction (SUSAR) reports, arising from Clinical Trials that are conducted under the EU Directive 2001/20/EC
  • Coordination of vigilance activities for BTO
  • Monitoring trends in reporting and contributing to signal detection activities, as appropriate
  • Editing and coordinating publicationof HPRAs Drug Safety Newsletter
  • Managing HPMs safety contribution and communications to journals, publications and other relevant fora

 

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

Role Profile    Recruitment portal application form



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