DXC Technology helps clients harness the power of innovation to thrive on change. For more than 60 years, we have successfully guided the world’s largest enterprises and government agencies through successful change cycles. We take pride in our technology independence and our role as a trusted advisor. Our deep experience gives us a clear and confident vision to help clients navigate the future. As the world’s leading independent, end-to- end IT services company, we are uniquely positioned to lead digital transformations — creating greater value for clients, partners and shareholders, and presenting growth opportunities for our people. We are among the world’s best corporate citizens.
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
Job Description
• 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;
Further requirements
• 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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Candidate Profile
MBBS, DR in Medical field, Pharmacy.
Other Qualifications
• 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
Additional Information:
Experience : 10+ years
Qualification : MBBS, DR in Medical field, Pharmacy
Location: CHENNAI
Industry Type: Pharma/ Healthcare / Clinical research
Functional Area : Clinical Safety
End Date : 31st March, 2018
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