DXC Technology is a technology company headquartered in Tysons Corner, Virginia. DXC provides information technology and consulting services to businesses and governments.
Post : Clinical Safety Officer
Type of work: Analyst and Highlight any clinical risk or issues that might occur whenever a software is developed or whenever a change is made.
- Embedding of end to end safety and regulatory requirements, gateways and processes into the Software Development Lifecycle as standard
- Ensuring adherence to the required global regulations and legislation for patient safety and product manufacturing, e.g. EU Medical Devices Directive 93/42/EEC
- Assisting with registration and certification of medical device / software products to facilitate sales within the global market
- Ensuring provision of a formalized, top down and cost effective approach to safety across globally – based on industry best practice, legislation and standards
- Identification of safety risks and issues at earlier stages in product development, resulting in significantly reduced potential for future safety incidents, fewer project delays and, therefore, reduced costs
- Improving overall product quality and end user experience
- Attending internal solution meetings to ensure clinical focus is maintained
- Applying their clinical knowledge to support the development of business process designs to ensure the solution meets the needs of the customer;
- Product knowledge or experience of using healthcare IT systems
- Medically Registerable qualification with relevant up to date practice within healthcare.
- Degree level (or experience equivalent) in a managerial or healthcare related subject
- Strong communication; skills able to deliver a message to people at all levels of the business who will have very different levels of domain knowledge
- Provide clinical consultancy and final approval of the product release clinical safety plans. A clinical safety plan describes the necessary clinical safety activities required to meet internal and external safety requirements for a specific product and release. Although standard practice is in place the plan should established for each release to ensure the clinical safety management elements add the most value possible to the production process and timescales.
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MBBS, DR in Medical field, Pharmacy
- Good oral and written communication skills to interface with internal and external clients and create appropriate knowledge assets
- Good analysis, critical thinking, and data synthesis skills
- Good organizational skills to balance and prioritize work to meet project margins
- Strategic knowledge and skill related to the industry being supported
Experience: 10+ years
Education: MBBS, DR in Medical field, Pharmacy.
Industry Type: Pharma/ Biotech/Clinical Research
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