Job Description

Overview:

As a Senior Vigilance Reporting Associate, where you will play a critical role in ensuring the safety and compliance of medical devices through meticulous vigilance reporting and regulatory submissions. This position is tailored for professionals dedicated to excellence in quality management and regulatory affairs within the healthcare and life sciences sector.

Key Responsibilities:

• Draft and thoroughly review medical device vigilance reports in English for submission to regulatory authorities, ensuring accuracy, clarity, and compliance with global standards.
• Collaborate closely with cross-functional teams including Quality Assurance, Regulatory Affairs, and Manufacturing to collect and analyze adverse event data related to medical devices.
• Maintain up-to-date knowledge of applicable regulatory requirements such as ISO 13485 and the USA Medical Device Regulation (MDR), interpreting and integrating changes into reporting practices.
• Identify potential safety signals and trends from vigilance data to support proactive risk management strategies and continuous product improvement.
• Ensure timely and compliant submission of vigilance reports adhering to specified protocols and deadlines, mitigating regulatory risk and promoting patient safety.
• Document and archive all reports and supporting evidence in accordance with company policies and regulatory mandates to facilitate audits and inspections.
• Participate in internal and external audits, providing expertise and documentation related to vigilance processes and reports.

Qualifications and Experience:

• At least 4 years of experience specifically in writing and managing vigilance reports for medical devices, demonstrating a strong command of regulatory expectations and quality standards.
• Exceptional written communication skills in English, able to convey complex medical and regulatory information clearly and professionally
• Sound understanding of ISO 13485, USA Medical Device Regulation, and other relevant international medical device standards and guidelines
• Proven ability to work with multidisciplinary teams in a collaborative and results-driven environment
• Detail-oriented, analytical thinker with a proactive approach to problem-solving and continuous improvement

Why Join Us? At Wipro, you will be part of a forward-thinking organization dedicated to innovation and excellence in the medical devices industry. We offer a supportive environment where your expertise is valued and you can grow your career while making a tangible impact on global patient safety.

͏

Support Process Responsibilities

• Ensure smooth and high-quality management of all process transactions

• Respond promptly, courteously, and professionally to all incoming client requests received via telephone and email, demonstrating excellent interpersonal skills.

  • Accurately record all essential end user identification information, including name, department, and detailed description of the issue or inquiry, maintaining data integrity and confidentiality.
  • Maintain and update real-time availability status within the RAVE system to maximize team productivity and workflow efficiency.
  • Track, document, and analyze all customer interactions, resolving issues effectively while documenting unsuccessful resolutions for process improvement.
  • Adhere strictly to standard operating procedures and quality standards to ensure compliance and high client satisfaction.
  • Resolve client queries within defined Service Level Agreements (SLAs), escalating complex issues timely to appropriate stakeholders to maintain service excellence.
  • Utilize and update internal knowledge bases and FAQs, contributing to a learning culture aimed at expeditious problem resolution.
  • Develop a deep understanding of product specifics and client needs to improve support quality and troubleshooting effectiveness.
  • Analyze call logs periodically to detect recurring issues and proactively develop preventive measures.
  • Create and maintain comprehensive self-help resources for clients to facilitate faster resolution of common issues.
  • Identify critical issues requiring urgent attention and escalate promptly to team leaders to ensure timely resolution and mitigate potential escalations.
  • Provide all necessary product information and disclosures to clients before and after interactions to ensure transparency and customer trust.
  • Comply with all contractual service agreements and legal guidelines to avoid potential legal challenges or compliance violations.

   

͏

Deliver Exceptional Customer Service Through Expert Diagnosis and Troubleshooting

• • Conduct thorough problem analysis by asking precise questions and guiding customers through step-by-step resolutions tailored to their unique concerns.
  • Assist clients in navigating product menus and features, enhancing their user experience and satisfaction.
  • Resolve client issues with a friendly, patient, and professional demeanor, fostering strong relationships and repeat business.
  • Maintain accurate and comprehensive logs of customer interactions and resolutions to support accountability and service tracking.
  • Utilize designated tracking systems to process and document all calls and emails efficiently, ensuring traceability and data accuracy.
  • Provide clients with alternative solutions when appropriate, aiming to retain customer loyalty and resolve issues effectively.
  • Communicate clearly and concisely, tailoring oral messages to fit the audience and situation for maximum understanding.
  • Conduct follow-up calls with clients according to schedule to gather feedback and confirm compliance with contractual obligations and SLAs.

͏

Build Capability for Operational Excellence and Sustain Superior Customer Service

• • Engage in continuous learning through product training sessions to stay abreast of feature updates, enhancements, and changes that impact service delivery.
  • Participate in client-specific and role-related training programs to develop skills and knowledge aligned with client expectations and industry best practices.
  • Collaborate with team leadership to identify recurring training needs and thematic learning opportunities that can elevate client service standards.
  • Commit to self-directed learning and expand professional networks to continuously enhance expertise and adaptability in a dynamic environment.

͏

Performance Delivery Metrics

Meeting these performance metrics ensures that individuals and teams maintain the high standards expected at Wipro, directly contributing to client satisfaction and continuous improvement.