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Pharmaceutical Assessor

3 months ago

London, Greater London, United Kingdom Medicines and Healthcare products Regulatory Agency Full time
We are currently looking for a

Pharmaceutical Assessor to join our

Import Notification System assessment team, in the

Healthcare Quality and Access Group.

This is a
full-time opportunity, on a
permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas.

Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.


We are currently implementing a flexible, hybrid way of working, with a minimum of 4 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business.

Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 8 days a month, with the remainder of time worked either remotely or in the office.

Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

***
Who are we?


The Medicines and Healthcare products Regulatory Agency enhances and improves the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.


The objective of the Healthcare Quality and Access Group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways.

It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards.


What's the role?


The post holder will work as part of the Import Notification System (INS) assessment team performing safety, and safety in relation to quality, vetoing of notifications of intent to import unlicensed medicines.


The INS is an MHRA function dedicated to the statutory duty of processing and assessing notifications of intent to import unlicensed medicines into the UK.


Key responsibilities:

  • Assess notifications for importation into the UK of unlicensed medicinal products received under SI 2005/2789 regulation 167 and Schedule 4 against known patient safety or product quality issues affecting unlicensed medicines, to determine if a non‐objection or objection to import should be issued. Decisions must be made in a timeframe appropriate to the urgency of the issue, and on the information available at that time.
  • Display a high level of attention to detail to ensure up to date accurate data and documents are held on internal databases and relevant archives.
  • Work with Department of Health & Social Care Medicine Supply Team and the NHS Commercial Medicines Unit to highlight and manage supply disruptions.
  • Work in conjunction with Importers, Manufacturers and Marketing Authorisation Holders to gather sufficient information to make informed decisions regarding supply of unlicensed medicines and to agree proposed courses of action.
  • Provide regulatory and scientific advice and guidance to MHRA colleagues across the agency and to external stakeholders to facilitate and enable continuity of supply of medicinal products in the UK.
  • Work with Communications and Engagement and Partnerships groups to ensure media handling and press lines are accurate, effective and commensurate to the risk.
  • Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders.
  • On call duty rota commitment

Who are we looking for?

  • Have experience in the Pharmaceutical Industry, NHS quality assurance or manufacturing roles, or relevant roles within a competent authority, and a thorough working knowledge of Good Manufacturing Practice and regulations underpinning pharmaceutical manufacture and distribution.
  • Have demonstrable experience of developing successful relationships with both internal and external stakeholders, with excellent communication skills.
  • Hold a degree in a relevant science (e.g. pharmacy, chemistry, pharmacology, medicine).
  • Knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities in relation to the pharmaceutical development, manufacture and quality assurance of human medicinal products.
  • Be able to work flexibly, with the ability to adapt to changing priorities and take responsibility for achieving a successful outcome
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification

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The selection process:

  • An
  • A

test; further information will be supplied when you re