Job responsibilities
Medical Assessor - Benefit Risk Evaluation (TAU 2, Immunology, Biocompatibility and Non-clinical team)
Pay Grade SCS1
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.
About the Group and Function
The Safety and Surveillance Group brings together into a single integrated structure devices and medicines safety expertise with enforcement capabilities. These functions will be supported by our data and evidence generating capabilities complementing our signal generating capabilities produced via the new Safety Connect System.
Medicines and devices have traditionally been regulated separately largely driven by different regulatory processes and ways of working. As science and technology drives increasing understanding of disease, it is also opening new opportunities for treatments with both functions. Product profiles are changing, becoming ever more complex and the boundaries between functions are blurring. These changes provide a unique opportunity to bring functional capabilities together to better address the regulatory challenges of the future. Against this background and the drive to improve treatment availability for patients, safety remains at the heart of our decision making. As such the core objective of the Safety & Surveillance Group is to protect the public from risks associated with medicines and medical devices by:
Ensuring a world class, comprehensive vigilance system that can promptly detect and monitor signals across the product life cycle
Evaluating the benefit risk of medicines and devices for which signals or other safety concerns emerge and developing effective and measurable risk mitigation measures
- Ensuring patients and other stakeholders are involved in the regulatory processes and appropriate messages are issued for patients and stakeholders following regulatory decisions
Deploying innovative interventions to reduce the criminal threat
Exploiting data and embracing new technologies to develop the evidence to support our actions and understand their impact
The Benefit Risk groups I and II within Safety and Surveillance comprise 10 teams covering the following the therapeutic areas:
Benefit Risk I
Benefit Risk II
Oncology, Haematology, Thrombotic disease
Musculoskeletal, Trauma and Cosmetic
Immunology, Biocompatibility and Non-Clinical
Respiratory, Imaging and Critical Care
Vaccines, Infectious Diseases and Diagnostics
Cardiovascular and Fluid Management
Senses, Movement and Pain
Metabolic and Renal Systems
Neuropsychiatric Disorders, Cognition and Mental Health
Gastrointestinal System, Nutrition, Endocrine and Fertility
There is one vacancy in the Immunology, Biocompatibility and Non-clinical team. Expertise in this therapy area is not essential.
Role Purpose
The Agency is facing a rapidly evolving external environment involving increasingly complex products and utilisation of these products across an ever more diverse health system.
Reporting to the Head of the Immunology, Biocompatibility and Non-clinical, a Medical Assessor is required to conduct assessment of a wide range of data, contributing to the Agencys wider vigilance activities and ensuring that safe and effective medicines and medical devices continue to be available to UK patients. They will analyse evidence from a range of sources as well as taking into account stakeholders and patients views to monitor the benefit: risk balance of medicinal products and devices in clinical use. The post holder will undertake effective matrix working as appropriate across the Benefit-Risk Evaluation functions, the wider Safety and Surveillance Group and Agency life-cycle Groups. The post holder will ensure that scientific, technical, and clinical benefit-risk assessment of potential safety issues takes place promptly and contributes to sound regulatory decisions regarding safety of medicines and devices.
Key responsibilities and results areas
In this key role you will
- evaluate the benefit: risk balance of medicinal products and medical devices in response to new data and make evidence-based recommendations for action to minimise risk and maximise benefit.
- use your regulatory expertise on risk management systems, supporting the agencys objective of safely bringing innovative products to patients as rapidly as possible.
- provide scientific advice and conduct assessments of risk management plans in support of new applications for innovative products
- present and discuss your scientific assessments with clinical and scientific expert advisory groups
- take actions to reduce newly identified risks associated with medicines and medical devices, ensuring timely and effective communications to healthcare professionals and patients.
- develop communications for the public, senior officials or ministers as required.
- maintain good working relationships with colleagues and with internal and external stakeholders
- apply your knowledge of relevant Regulations and regulatory procedures
- extend skills and knowledge in relevant scientific or professional areas to maintain an influential role
The job description is not intended to be exhaustive and it is likely that duties may be altered from time to time in the light of changing circumstances and after consultation with the post holder.
Person Specification
Important Candidate information:
The Civil Service recently launched a new recruitment framework called Success Profiles, which has replaced the Civil Service Competency Framework.
Success Profiles are made up of 5 elements: Ability, Behaviours, Experience, Technical, Strengths but it is unlikely that you will be assessed against all 5.
Behaviours, Experience and Technical elements will be assessed through your application form, in the first instance.
Element
Behaviours
The actions and activities that people do which result in effective performance in a job.
Criteria
- Making Effective Decisions: critically analyse clinical/scientific information from a range of sources including case reports, clinical trials and observational studies, make sound judgements for recommendations to protect patient safety and public health.
- Use evidence and knowledge to support accurate, expert decisions and advice. Carefully consider alternative options, implications and risks of decisions.
Apply clinical/scientific perspective to benefit risk evaluations and advise others in the team
- Delivering at Pace: Evidence of ability to work in a pressurised, target driven environment, delivering results on time within a range of deadlines maintaining high standards of quality.
Evidence of flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.
- Communicating and Influencing : Ability to communicate with others internal and external to the agency in a clear, honest and enthusiastic way in order to explain complex issues and to build trust.
- Working Together: Use evidence and knowledge to support accurate, expert decisions and advice. Carefully consider alternative options, implications and risks of decisions.
Assessment
Application, Interview, Test
Element
Experience
The knowledge or mastery of an activity or subject gained through involvement in or exposure to it.
Criteria
- Excellent written communication skills, including the ability to write authoritative reports. Excellent verbal and presentation skills
- Excellent interpersonal skills to facilitate team-working/team-leading, consulting and co-operating with colleagues from different disciplines and with variable degrees of expertise.
Sound knowledge and understanding of the relevant regulatory procedures
Assessment
Application, Interview,
Element
Technical
The demonstration of specific professional skills, knowledge or qualifications.
Criteria
- Medically qualified and registered to practice with the General Medical Council
- Clinical, academic or pharmaceutical medicine experience, including evidence of an up-to-date specialist level of knowledge and evidence of analysis of data and preparation of reports, scientific publications or reviews or manuscripts for regulatory submissions.
Assessment
Application, Interview,
Element
Strengths
The things we do regularly, do well and that motivate us.
Criteria
- Decisive: You use your judgement and take a considered approach to situations and tasks when making decisions.
- Responsible: You take ownership for your decisions and hold yourself accountable for what you have promised to deliver.
- Strategic - You look at the big picture and consider the wider factors and long term implications of decisions.
Assessment
Interview
