Pharmacovigilance PV Manager - Cancer Research UK Clinical Trials UnitGrade 8
Pharmacovigilance PV Manager - Cancer Research UK Clinical Trials UnitGrade 8
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£ 46735 - 55755
1 Vacancy
Job Description
Position Details
Cancer Research UK Clinical Trials Unit School of Medical Sciences College of Medicine and Health
Location: University of Birmingham Edgbaston Birmingham UK
Full time starting salary is normally in the range 46735 to 55755 with potential progression once in post to 62728
Grade: 8
Full Time Permanent
Closing date: 21st April 2025
Our offer to you
People are at the heart of what we are and do.
The University of Birmingham is proud to have been a part of the City of Birmingham and the wider region for over 100 years andweare equally proud to be recognised as a leading global university.We want to attract talented people from across the city and beyond support them to succeed and celebrate their success.
We are committed to helping the people who work here todevelopthrough our sectorleading Birmingham Professional programmewhichprovides allprofessionalservices staff with development opportunities and the encouragement to reach their full potential.With almost 5000professionalservices jobs in a widerange of functionsin Edgbaston andin our campus inDubai there are plenty of opportunities foryou to be able to develop yourcareer at the University.
We believe there is no such thing as a typical member of staff and that diversity is a source of strength that underpins the exchange of ideas innovation and debate.We warmly welcome people from all backgrounds and are committed to fostering an inclusive environment where diversity is at the heart of who and what we areand how we work.
Supporting our people to achieve a healthy work/life balance is important both to our employees andtothe success of the University and depending on the role we offer avarietyof flexible working arrangements. We therefore welcome discussions on all forms of flexible working addition you will receive a generous package of benefits including 40 dayspaid holidaya year one paid day a year for volunteering occupational sick pay and a pension scheme. We also have three high quality subsidised day nurseries.
The University is situated in leafy Edgbaston and there are excellent transport links to our beautiful campus including main bus routes and a train station on site.On campus we have a stateoftheart sports centre with pool shopsplaces to eat and drinkour own art gallery museum and botanical gardens.
Find out more about thebenefits of working for the Universityof Birmingham
Background
The Cancer Research UK Clinical Trials Unit (CRCTU) is one of two UK Clinical Research Collaboration (UKCRC) registered clinical trials units (CTUs) at the UoB. The CRCTU was established over 50 years ago and is now an integral part of the School of Medical Sciences. It has grown to be one of the largest cancer specialist trials units in the UK delivering high quality clinical research across a broad portfolio of disease types and treatment modalities in all phases of clinical trials.
The CRCTU comprises a highly qualified and knowledgeable team of 200 members of staff including biostatisticians clinical academics trial managers programmers research nurses quality management information technology administration and finance staff who together form the professional infrastructure that is essential to the delivery of scientifically excellent and regulatory robust clinical trials.
CRCTU has strong collaborative links with local national and international investigators in the design and conduct of trials with particular emphasis on international collaboration for the paediatric portfolio and for rare diseases using innovative and worldleading expertise in trials methodology to enable important clinical questions to be addressed in challenging situations.
The CRCTU also hosts a portfolio of early phase noncancer trials and is an important component of the National Institute of Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC) which focuses on inflammation and diagnosis prevention and treatment of its associated longterm illnesses which include: Arthritis; Infection and Acute Care; Liver Disease;Womens Metabolic Health;Cancer Inflammation;Oral Intestinal and Systemic Health. The CRCTU being key to the design delivery analysis and publication of Birmingham BRC trials.
Role Summary
An integral part of clinical trials involves the collection analysis and reporting of safety information and adverse events including adverse reactions and the identification of any event that is serious and unexpected.It is essential that cases are assessed and reported appropriately in compliance with applicable legislation.
The trials portfolio within CRCTU is broad and includes Clinical Trials of Investigational Medicinal Products (CTIMPs) nonCTIMP trials device trials and trials of Advanced Therapy Investigational Medicinal Products (ATIMP) for which safety reporting requirements may vary.
The post holder will lead on pharmacovigilance (PV) and safety reporting within the CRCTU working closely with the CRCTU Director of Operations to develop and maintain appropriate systems and to meet reporting requirements. Activities will include advising on (and where applicable assessing) Serious Adverse Events (SAEs) preparation of development safety update reports and regulatory reporting to the Medicines for Health Regulatory Agency (MHRA) Individual Case Study Report (ICSR) and the European Medicines Agency (EMA) EudraVigilance systems. The post holder will also identify areas of ineffective working for PV and safety reporting activities and develop approaches to improve operational effectiveness.
Main Duties
Leadership and management duties
- Lead on PV and safety reporting ensuring that regulatory timelines are met.
- Lead and motivate staff responsible for the daytoday conduct of PV activities. Responsibility for PV staff management development appraisal and training.
- Promote open and active communication between PV and other teams involved in trial delivery.
- Develop processes for safety reporting write and review Standard Operating Procedures (SOPs) and supporting documents.
- Maintain an overview of SAE reporting within the Unit ensuring regulatory timelines are met and SOPs followed.
- Regularly review safety reporting activity and systems within and across CRCTU trials identifying any patterns concerns or inefficiencies. Develop and implement appropriate improvements or corrective actions.
- Investigate concerns over persistent problems and issues related to noncompliance misconduct or fraud in relation to safety reporting with support from the CRCTU Director of Operations Quality Assurance Manager and other senior staff.
- Provide specialist advise to staff and stakeholders.
- Support CRCTU Directors and Team Leaders in meetings with pharmaceutical companies and other third parties.
- Represent the Unit in audits and inspections regarding PV activities assist in the development and delivery of internal PV audits and development of appropriate corrective and preventative actions.
- Act as a member of the CRCTU Operational Management Committee. Communicate policy and decisions positively to staff.
- Prepare and present reports on PV activities including regulatory compliance to the CRCTU Operational Management Committee and others as required.
- Represent the CRCTU at (inter)national meetings. Contributing to working parties/committees at a local and (inter)national level.
Trial development/setup
- Advise Chief Investigators and trial teams on appropriate safety reporting content for trial protocols and supporting documents in line with SOPs relevant guidelines applicable regulations and legislation.
- Advice on the wording of safety and quality agreements with regard to PV and safety reporting.
- Advice on trial risk assessments regarding safety reporting risks.
During trial
- Advise on coding of adverse events (AE) and assessment of expectedness.
- Where needed process SAEs ensuring data is entered into the database that SAEs are appropriately categorised and reported (if applicable) that data is complete and accurate.
- Fulfil regulatory requirements for reporting to competent authorities and ethics committees (e.g. SUSARs).
- Work with trial teams to meet timelines on SAE data exchange with companies or other collaborating partners.
- Work with trial and data teams to ensure that AE/SAE reconciliations is performed.
- Lead writing and reporting of Development Safety Update Reports (DSURs) and other periodic reports as required. Obtain appropriate input review and approval by Chief Investigators.
End of trial
- Provides input and review of the safety sections of final Clinical Study Reports.
General
- Convey and understand communication of a highly specialist and sometimes complex nature which typically would not be understandable to nonspecialists.
- Maintain a thorough understanding of regulation guidelines and governance applicable to safety reporting in clinical trials and studies undertaken by CRCTU. Maintain high standards of best practice within PV and safety reporting.
- Teach on postgraduate course delivered by the University as required.
- Proactively plan in order to meet the deadlines and requirements of legislation.
- Undertake training as required for the post at the discretion of the CRCTU Director of Operations.
Required Knowledge Skills Qualifications Experience
Essential
- Education to BSc level in a biomedical or a related sciences subject or other relevant qualification.
- Experience of PV/safety reporting activities in) CTIMPs including assessment of SAEs regulatory reporting to competent authorities and ethics committees writing and submitting DSURs.
- Experience of working with a coding dictionary such as MedDRA or other standards such as NCI CTCAE.
- Experience of providing training in a clinical trial management setting.
- Experience of writing and implementing written procedures.
- Experience of managing patient data within a clinical trial or clinical study.
- Computer literate including Microsoft Office packages and databases (MS Office).
- Accurate and methodical with excellent attention to detail.
- Excellent communication skills.
- Ability to travel easily in the UK and further afield on rare occasion. For some visits it may be necessary to stay overnight.
- Knowledge of the protected characteristics of the Equality Act 2010 and understands how to ensure in day to day activity in own area that those with protected characteristics are treated equally and fairly.
- Support the delivery of clinical research in accordance with Good Clinical Practice (GCP) the Declaration of Helsinki applicable legislation (including but not limited to the Medicines for Human Use Clinical Trials Regulations Data Protection Act 1998 Human Tissue Act) the Research Governance Framework for Health and Social Care Caldicott principals and applicable NHS Trust and University policies and procedures (including but not limited to the Universitys Data Protection Policy Information Security Policy and Code of Practice for Research) in order to protect the research subject and the quality of each study.
Desirable
- Postgraduate PV qualification.
- Experience of early phase oncology clinical trials.
- Experience of device trials run within UK legislation.
- Experience of clinical trial safety reporting systems and requirements outside the UK especially EU countries.
Role Context
Roles at this level provide authoritative professional advice across a range of activities and/or will lead and manage diverse team(s) and resources.You will use your professional skills to resolve problems where the solution is not immediately apparent. Significant evaluation and independent thought is therefore required to resolve ambiguity. You will have wide discretion to decide on direction whilst ensuring activities are broadly consistent with operational policies. You will be able to influence policy through advising on the impact of policy change and implementation in your area of work.You will need to assess the impact of your activities across your area with related areas and to ensure they fit with the broader objectives of the University.
Core competencies/transferable skills
Working at this level you will be able to develop and successfully use the following core competencies/transferable skills in each of the areas shown below.You will be expected to take ownership for getting things done including calling on or joining others to assist.You will be expected to be flexible as required in supporting your department and wider University.
Planning and organising:
- provide professional expertise and manage resources and/or a diverse team;
- integrate and coordinate work across different parts of the department;
- lead and manage staff who are likely to be carrying out diverse duties and ensure collaborative working to deliver a successful service;
- project manage activities to facilitate changes;
- develop policy within functional guidelines and contribute to strategic development within own area; and
- be accountable for the quality and professionalism of service delivery with an appreciation of longer term issues.
Problem solving and decision making:
- anticipate interpret and assess customer needs identifying trends generating original ideas and testing innovative solutions;
- deal with significant people management issues such as performance management; and
- resolve issues which may not have arisen before through use of experience and judgement.
Organisational understanding:
- have an excellent understanding of own working area and a broad understanding of the contribution other areas make to the success of the University;
- have an excellent understanding of how the University operates together with an understanding of how academia operates in the UK; and
- demonstrates empathy with the academic endeavour and seeks to encourage others to do so.
Relationships and communication:
- use coaching skills to motivate and develop staff;
- proactively and sensitively manage the team and create a motivating environment;
- influence others (including across the University) to follow a particular course of action; and
- represent the department at internal and external meetings/events/network with colleagues in other institutions to share best practice.
Further particulars can be foundhere
Informal enquiries to Dr Sarah Bowden email:
View our staff values and behaviourshere
We believe there is no such thing as a typical member of University of Birmingham staff and that diversity in its many forms is a strength that underpins the exchange of ideas innovation and debate at the heart of University life. We are committed to proactively addressing the barriers experienced by some groups in our community and are proud to hold Athena SWAN Race Equality Charter and Disability Confident accreditations. We have an Equality Diversity and Inclusion Centre that focuses on continuously improving the University as a fair and inclusive place to work where everyone has the opportunity to succeed. We are also committed to sustainability which is a key part of our strategy. You can find out more about our work to create a fairer university for everyoneon our website.
Required Experience:
Manager
Employment Type
Full-Time
