Associate - Triage data surveillance specialist

Job Description

*With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world s biggest brands and we have fun doing it. We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We re harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we re calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing., People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower. Come, transform with us.Inviting applications for the role of Associate, Regulatory Services- Triage data surveillance specialist On Site Gurgaon India Your job will involve evaluating discovery report for all medical devices distributed by our client and generating FUC (Final Universal Code). Determines if investigation is required (Tier determination). Closure of the complaint by integrating the FUC into the ETQ Database.What will your day-to-day role involve Responsibilities Interaction:
• Works with end customer, indirect customers and internal stakeholders of the customers
• Works with Ops leads and customers to design, implement and drive Value Generating [VG] roadmaps
Activity:
• The candidate will be doing a technical analysis and evaluate the outcome of the problem.
• Receiving reports from field engineers, technicians - they are looking at reports and determining if the problem is an issue or a non-issue from a patient safety perspective
• Determine the severity of the problem and next actions.
• Entering info from the service report into the digital tool (ERP) - ETQ
• Make a decision and complete evaluation by classifying the issue into a tier.
• They have some evaluation options (IUC - intake universal code)- e.g. Someone got hurt in the incident,
• Talking to the technicians who sent the reports for more details
• Support the training of employees on the complaint process and regulatory requirements.
• Explain complaint files during audit situations.
• Reviews files for closure and completeness.
• Determination if investigation is required (Tier determination)
• Final evaluation & closure of Tier 3 complaint
Qualifications we seek in you Minimum qualifications
• Bachelors Degree (Engineer or similar is preferable)
• Critical thinking / decision making
• Administrative duties - precision, data accuracy
• Communications - investigative affinity
• Quality assurance background/medical device background advantageous
• Potentially candidates with previous SQE or Technical support experience
• Asking the right questions
Preferred Qualifications
• High motivation and agility to learn new things
• Ability to work under time pressure
• Good professional communication skills
• Relevant years of experience
• Technical education and background
• Previous experience as repair service technician, incoming inspector or final inspector
• Formal qualification in engineering preferred
• Local (English, Spanish, Russian, Czech, Japanese) language skills (discovery report in local language)
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation.,

Keyskills :
customer focuspatient safetymedical deviceslanguage skills