Good Pharmacovigilance Practice Inspector - 57,028 - 68,422 p.a. + Market Pay Supplement of 6,000 p.a. + benefits

We are currently looking for a Pharmacovigilance Inspector to join our Standards and ComplianceFunction within the Health Quality and Access group.

This is a full-time opportunity, on a permanent basis. The role is a homebased role but will require occasional travel to 10 South Colonnade, Canary Wharf London, E14 4PU/South Mimms, Hertfordshire and other inspection sites. Please be aware that this role can only be worked in the UK and not overseas.

Who are we?

The Medicines and Healthcare products Regulatory Agency enhance and improve 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 portfolio is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways.

Whats the role?

The postholder will be a part of the GPvP Compliance Team whose remit is to perform inspections at a wide range of sites in the UK (and potentially overseas) to assess the compliance of organisations with their legal obligations. The role also involves engaging with stakeholders across a variety of platforms to help improve industry compliance and contribute to safeguarding public health.

As Pharmacovigilance Inspector, you will be part of a dynamic and supportive team. In your role, you will have autonomy in how to plan and structure your day-to-day work, including inspections.

It is a condition of employment that inspectors are willing and able to travel on company business. Travel will predominantly be required across the UK, but occasional overseas travel may be necessary. You will also be required to attend our two sites (Canary Wharf, London; Potters bar, Hertfordshire; and other government buildings) for in-person meetings and training events.

This post is aimed at candidates with substantial pharmacovigilance knowledge and significant experience as a GVP Inspector within a Regulatory Agency. If successful, initial employment will start at Grade 7 and you will receive a market pay supplement of 6,000 per year. You will then be expected to be performing at the level of an MHRA accredited inspector within 6 months of your starting date.

The recruitment process consists of an application form, interview and online/virtual aptitude tests aimed at evaluating your experience and knowledge of pharmacovigilance as well as your technical abilities and behaviours which will help you succeed in this role.

Key responsibilities:

• To perform GPvP inspections of marketing authorisation holders and their service providers, primarily within the UK but also potentially overseas. This includes planning, conducting and reporting inspections and assessing the adequacy of responses from the inspected organisation.
• To contribute to the GPvP Compliance Teams compliance management process to ensure that instances of suspected or known non-compliance are handled appropriately.
• To engage effectively with external stakeholders across a variety of platforms.
• To work closely across inspection teams, Agency departments and external regulators to ensure inspection activities are planned and communicated effectively.
• To support the continued development of the Compliance Team quality system by maintaining current knowledge and expertise in relevant scientific, professional and administrative matters.

Who are we looking for?

Our successful candidate will demonstrate the following:

• A degree in a relevant science, medical or engineering degree (e.g. pharmacy, chemistry, microbiology, pharmacology, biochemistry, biology, medicine, engineering).
• Experience of working in Good Pharmacovigilance Practice in a pharmaceutical orientated regulatory environment and significant experience of working as a GVP inspector for a Regulatory Agency.
• Ability to work unsupervised for long periods of time, but also able to work within a team environment demonstrating good planning and organisational skills to meet tight deadlines and manage multiple priorities.
• Proven ability to analyse and identify issues, make sound decisions, take appropriate actions tactfully and effectively, influence key stakeholders and take responsibility for results.
• Excellent verbal and written communication skills.
• IT literate including skills in Microsoft Office.

Method of assessment: A=Application, T=Test, I=Interview, P=Presentation

Ability Criteria:

• Good verbal and numerical reasoning skills to allow the analysis and interpretation of written and numerical data. (T)

Behaviour Criteria:

• Managing a Quality Service (A, I)
• Working Together (A, I)
• Delivering at Pace (A, I)
• Making Effective Decisions (A, I)
• Communicating and Influencing (A, I)

Experience Criteria:

• Experience working in a relevant GXP area to the job application (e.g. GCP, GLP, Laboratories, GPvP). (A, I)

Technical Criteria:

• Degree in a relevant science, medical or engineering degree (e.g. pharmacy, chemistry, microbiology, pharmacology, biochemistry, biology, medicine, engineering). (A, I)
• IT literate including skills in Microsoft Office. (A, I)
• Proven ability to write well-focused penetrating reports fully independently, to resolve critical issues and make effective presentations. (A, I)
• Proven ability to work unsupervised for long periods of time, but also able to work within a team environment demonstrating good planning and organisational skills to meet tight deadlines and manage multiple priorities. (A, I)
• Proven ability to analyse and identify issues, make sound decisions, take appropriate actions tactfully and effectively, influence key stakeholders and take responsibility for results. (A, I)

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!

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