Regulatory and Pharmacovigilance Specialist

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About the job

Do you have multiple years of experience in regulatory and pharmacovigilance activities? Are you open to exploring a new career opportunity? 

Invenia Group is partnered with a global pharmaceutical business, searching for a Regulatory and Pharmacovigilance Specialist to join its team of experts. This role will see you having responsibility as the local Responsible Person for Pharmacovigilance in Ireland, as well as supporting maintenance activities and providing specialist advice for new products.

Roles and responsibilities:

If successful, you will be responsible for the following:

  • Ensure all activities required for the launch of new products in Ireland are conducted
  • Maintain the portfolio of products marketed in Ireland
  • Oversight of the patient safety hub, working with the other Marketing Authorisation Holders and the supplier to ensure ongoing compliance and meeting the expectations of the HPRA
  • Supporting the Director in ensuring that the regulatory function is inspection ready at all times
  • Creation and maintenance of Standard Operating Procedures and other regulatory documents to ensure compliance is maintained
  • Act as Local Responsible Person for Pharmacovigilance in compliance with company SOPs, GVP, and national regulations
  • Implement and maintain the local PV system in compliance with GVP and regional and local procedures and requirements
  • Identify a backup to ensure a business continuity plan and document the handover before and after the LRP absence
  • Development and maintenance of local Standard Operating Procedures as applicable
  • Ensuring induction and refresher PV training for the local Team, external partners, and vendors
  • Ensure an appropriate collection, documentation, translation (into English), follow-up, archiving, and timely transmission to the applicable functions of case reports and/or any safety information concerning company products
  • Coordinate the approval and implementation of local additional RMMs with local NCA and internal/external partners
  • Maintain awareness of any local PASS and/or PAES
  • Respond to Health Authorities PV related requests in collaboration with corporate functions
  • Perform or outsource local literature search on local medical and scientific (non-indexed) journals
  • Ensure that local internet and digital media are screened for safety information
  • Ensure local regulatory intelligence, by continuously monitoring the sources of regulatory intelligence
  • Supervise local PV subcontractors’ activities, including maintenance of contracts, and ensuring that appropriate auditing is performed
  • Inform the applicable QPPV of any third-party agreements (sub-contractors) which may have PV implications, at the beginning of the process/as early as possible
  • Participate and support PV audits and inspections as applicable
  • Ensure archiving of all documentation related to PV
  • Prepare and provide monthly reports to the applicable functions

What we are looking for: 

We are looking for someone with multiple years of experience in regulatory and pharmacovigilance activities. You should have a pharmaceutical or healthcare background, and flexibility in line with changing priorities. Excellent communication and interpersonal skills are also essential for this role, as well as experience with software packages such as Word, Excel, and Outlook.  

If you are interested in proceeding with this opportunity, please apply so we can arrange a confidential discussion to discuss the position in more detail.