Pharmacovigilance and Safety Specialist – Grade 5 – Deadline Sat 13th August

Pharmacovigilance and Safety Specialist – 14789BR.
To find out more – go to: – https://www.cardiff.ac.uk/jobs – search under Managerial, Administration and Support Vacancies

School of Medicine – Managerial, Professional and Specialist Staff – MPSS

Pharmacovigilance and Safety Specialist – Centre for Trials Research – College of Biomedical & Life Sciences

The Centre for Trials Research (CTR) at Cardiff University is the largest group of academic clinical trials staff in Wales, and has earned full UK Clinical Research Collaboration (UKCRC) registered status. The Centre tackles the big diseases and health concerns of our time, including growing resistance to antibiotics, early cancer diagnosis and how to eliminate health inequalities. It achieves this by forming partnerships with researchers and building lasting relationships with the public, whose participation is essential for the success of studies.

As part of our continued growth, an exciting opportunity has arisen for a Pharmacovigilance and Safety Specialist to join the CTR.

We are seeking a Professional Specialist in Pharmacovigilance and Safety to ensure the accurate entry, coding and reporting of all pharmacovigilance and safety data, and to provide support and advice to the trial teams on the pharmacovigilance and safety requirements dictated by the Clinical Trials Regulations.

You should have a Degree/NVQ 6 or equivalent Professional membership/experience, substantial experience of working within a research or clinical trials environment, with demonstrable administrative experience, and the ability to work unsupervised to deadlines, planning and setting priorities for own work and that of others and monitoring progress. Applications from graduates (or equivalent experience) with excellent administrative skills are encouraged.  Experience of working in PV & S, research governance or quality assurance environment is advantageous, however a comprehensive training programme is available.
For informal queries, please contact Kelly Gee, Regulatory Affairs Manager on 02920 687478 or email geekm@cardiff.ac.uk

This post is full time (35 hours a week), available from 1st November 2022 and is fixed term until 30th June 2023.
Salary: £27,924 – £32,344 per annum (Grade 5).

Date advert posted: Wednesday, 27 July 2022

Closing Date: Saturday, 13 August 2022

Cardiff University is committed to supporting and promoting equality and diversity and to creating an inclusive working environment. We believe this can be achieved through attracting, developing, and retaining a diverse range of staff from many different backgrounds. We therefore welcome applicants from all sections of the community regardless of sex, ethnicity, disability, sexual orientation, trans identity, relationship status, religion or belief, caring responsibilities, or age. In supporting our employees to achieve a balance between their work and their personal lives, we will also consider proposals for flexible working or job share arrangements.

Job Description

Job Purpose

Support the Centre with Pharmacovigilance & Safety (PV & S), carrying out supporting work, providing advice, guidance and support, and leading projects within this area

Duties and Responsibilities

Key Duties
• Provide professional advice and guidance on PV & S processes and procedures to internal and external customers, using judgement and creativity to suggest the most appropriate course of action where appropriate, and ensuring complex and conceptual issues are understood
• Support PV & S for individual projects, creating recommendation reports, supported by advances within regulation and best practice.
• Ensure that the provision of PV & S is delivered to the Centre, proactively changing the delivery according to customer requirements
• Collaborate with others in order to make recommendations for developments of established processes and procedures
• Establish working relationships with key contacts, developing appropriate communication links with the University’s Schools/Directorates and outside bodies as required
• Create specific working groups from colleagues across the University to achieve Centre objectives
• Supervise specific project teams on an occasional basis to accomplish key objectives
• Develop and deliver training within PV & S
• To engage in more general Quality Assurance work as appropriate
• Undertake a variety of administrative duties to support the Centre
• Instruct and guide other employees across the University within PV & S as required
• Ensure that work is undertaken and documented in a regulatory compliant way and be prepared for regular audits and inspections, as well as contributing to the development of the Quality management system for the area of PV & S

General Duties
• Ensure that an understanding of the importance of confidentiality is applied when undertaking all duties
• Abide by University policies on Health and Safety and Equality and Diversity
• Perform other duties occasionally which are not included above, but which will be consistent with the role

Person Specification

Essential Criteria

Qualifications and Education

1. Degree/NVQ 6 or equivalent Professional membership/experience

Knowledge, Skills and Experience

2. Substantial experience of working within a research or trials environment, with demonstrable administrative experience
3. Able to demonstrate professional knowledge of PV & S regulatory requirements to give advice and guidance to internal and external partners
4. Ability to set up standard systems and processes

Customer Service, Communication and Team Working

5. Ability to communicate conceptually detailed and complex information effectively and professionally with a wide range of people
6. Evidence of ability to explore customers’ needs and adapt the service accordingly to ensure a quality service is delivered

Planning, Analysis and Problem solving

7. Evidence of ability to solve expansive problems using initiative and creativity; identifying and proposing practical solutions and resolving problems with range of potential outcomes
8. Evidence of demonstrable knowledge of key advances within PV & S
9. Evidence of ability to work unsupervised to deadlines, planning and setting priorities for own work and that of others and monitoring progress.

Other

10. A willingness to undertake further training and development

Desirable Criteria

1. Experience of working with industry
2. Postgraduate/Professional qualification
3. Experience of working in PV & S, research governance or quality assurance environment.
4. Fluency in Welsh, written and oral

Additional Information

IMPORTANT: Evidencing Criteria

It is the School of Medicine’s policy to use the person specification as a key tool for short-listing. Candidates should evidence that they meet ALL of the essential criteria as well as, where relevant, the desirable. As part of the application process you will be asked to provide this evidence via a supporting statement.

Please ensure when submitting this document / attaching it to your application profile you name it with the vacancy reference number, in this instance for this post, 14789BR.

If candidates do not provide written evidence of meeting all of the essential criteria then their application will not be progressed. The School of Medicine welcome the submission of CVs to accompany evidence of the job-based criteria.

Salary Range Min.27,924
Salary Range Max. 32,344

Grade 5

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