Benefit Risk Evaluation Assessor
4 weeks ago
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 new 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 signals and developing effective and measurable risk mitigation measures 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 There is a fixed term opportunity until 28 February 2025 in the Metabolic Disorders and Renal Systems Benefit Risk Evaluation team. The Metabolic Disorders and Renal Systems Benefit Risk Evaluation team (TAU 9) monitors the safety of medicines and medical devices across these therapy areas. The team monitors the safety of medicines and medical devices across these therapy areas, including a wide portfolio of products for the treatment of genito-urinary and metabolic disorders, including rare storage diseases, as well as haemodialysis and access devices. Safety and Surveillance: Benefit Risk Evaluation Teams 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 Skin, Senses, Movement and Pain Metabolic and Renal systems Neuro psychiatric conditions, cognition and mental health Gastrointestinal System, Nutrition, Endocrine and Fertility Role Purpose The core purpose of this role is to provide a robust benefit risk assessment of potential safety signals using data from a range of sources and technical, scientific, clinical and regulatory knowledge and/or practical experience.
Ensure communication has a clear purpose and takes into account peoples individual needs. Share information as appropriate and check understanding. Making Effective Decisions - Display confidence when making difficult decisions, even if they prove to be unpopular. Consult with others to ensure the potential impacts on end users have been considered.
Gain a clear understanding of customers needs and expectations. Act to prevent problems and provide solutions. Assessment A, I Element Experience Criteria Managing complex projects to agreed milestones, managing conflicting priorities and the work of others Previous relevant experience such as healthcare, medical device or medicinal product manufacturing or regulatory environment Conducting benefit risk evaluations of medical devices and or medicines is desirable Assessment A, I Element Technical Criteria Degree or equivalent qualification in a related discipline (such as physical and/or biological sciences, pharmacy, engineering or a relevant healthcare qualification) or relevant experience Understanding of risk management principles to reduce harm (direct or indirect). Technical knowledge and/or practical experience of a range of medical devices and/or medicines within a therapeutic area Assessment A, I Element Strengths Criteria Analytical - You seek and analyse information to inform decisions based on the best available evidence.
Adaptable - You can adapt to variations in work or environment and your effectiveness isnt impacted by change. You are flexible and versatile and act as an advocate for change. Networker - You proactively create and maintain positive, professional and trusting working relationships with a wide range of people within and outside the organisation. You identify connections and reach out to bring people together.
Assessment I The Civil Service Code The
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