Our client is looking for a Safety Signal Detection Scientist who will use your specialist knowledge to develop relationships within the Patient Safety Center of Excellence team.
The role will initially be a 6-month contract working remotely due to COVID-19.
This role will drive the delivery of innovative business solutions to ensure that systems can scale to process the large volume of vaccine data and algorithms specific to vaccine surveillance are implemented.
The role requires a high level of interactive communication to set clear direction for the delivery team(s) and directly advises others at a high level, as well as exhibiting cultural sensitivity.
You will also be required to manage high level risk by making complex judgements, developing innovative solutions and applying a comprehensive cross-functional understanding.
Education, Qualifications, Skills and Experience
Essential
• Bachelor’s degree in a scientific discipline, with relevant experience in leading safety-related activities in the context of clinical biopharmaceutical development.
• Experience of formal system ownership.
• Broad knowledge of the safety activities required to support drug development and marketed brands, including a comprehensive understanding of clinical trials, regulatory safety obligations, pharmacovigilance practices, epidemiology practices, and changing safety project team activities.
• In depth knowledge of the procedures, processes and standards governing clinical trial data (documents and data) with health authorities worldwide, and experience of implementing these within the business.
• Able to identify opportunities, win support for and instigate/ lead change in safety analytics through innovation – seeking continuous improvement based on strong awareness of external competitive practice.
• Exerting Influence Without Authority.
• Able to manage projects through ambiguity and uncertainly.
Desirable
• Higher degree in a clinical, informatics, or safety-related discipline.
• Significant experience in pharmacovigilance with proven record of developing analytical solutions to address safety research problems.
• Knowledge of system validation, audit and PV inspection activities and requirements.
• Ability to articulate complex safety-related business needs in the context of IS systems design, architecture and development.
• Experience of enabling innovation and managing change within a global organisation
• Business awareness of wider development within the pharmaceutical industry, particularly in relation to the design and deployment of data sources, analytical tools, informatics solutions and systems.
• Experience across multiple therapeutic or business areas, or in working in safety-related roles within other biopharmaceutical, regulatory, or health organizations.
• Key capabilities commensurate with the Global Career Level of the role (e.g. Leadership Capabilities)
• Highly developed strategic and conceptual thinking, with ability to understand multiple, complex business needs and identify ways in which existing, or newly designed information or analytics solutions could address these in an effective and efficient manner.
• Experience in working across different geographic locations, organisations, and cultures.
If interested please call Glen Fairbrother on 02079401212 / glenf@msigroupltd.com
