Pharmacovigilance Risk Communication & Assessment (PvRCA) Manager - Human Products Monitoring (HPM)

Closing date for applications: 30/03/2023

Role Summary

The Human Products Monitoring (HPM) 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 PvRCA manager is a new post being introduced to the HPM department to enable delivery on the HPRAs strategic plan, and in particular our goals to strengthen partnerships with the health system and to develop our approach to patient/public engagement, as it relates to medicines safety issues and national risk management.

Reporting to the Director of HPM, the PvRCA manager will establish and manage a new section within the HPM department. They will lead our communication and engagement strategy with health care professionals, the health system, academia, patient/public organisations and industry to promote the role of HPRA in safety monitoring and risk management of medicines in clinical use. This includes advocating for the adoption and implementation of important safety recommendations, and ensuring the needs of the Irish health system and the public are fully integrated into our national risk management assessment approach.


Key Responsibilities

  • Representing the HPRA to senior leadership across the health system and learned societies, building meaningful relationships that can advance HPRAs strategic plans, and work towards a cohesive and joined up response to adoption of regulatory advice on risk management of medicine safety issues.

  • Ensuring HPRAs role in safety monitoring of medicines in clinical use is promoted across the health system, including as part of the HPRAs education policy and as part of outreach and engagement and proactively seeking opportunities to present and engage with relevant key stakeholders.

  • Developing intelligence and relationships across key partners in relation to above, including building on novel partnerships and approaches to support a coordinated and cohesive response to medicine safety issues.

  • Developing national approach to evaluating effectiveness of risk minimisation, building existing academic partnerships and the role of HPRA as a collaborator.

  • Leading the response to HPM related media queries and engagements, together with HPRA corporate communications team.

  • Developing the approach to risk minimisation nationally, from communication to implementation, taking account of relevant advances in the area of risk management and implementation science.

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

Role Profile                                  Application form

« Back