Summary
Overview
Work History
Education
Skills
Certification
Software
Timeline
Anoop Prahalladacahar

Anoop Prahalladacahar

Senior MDR/Vigilance Specialist
Hyderabad

Summary

With enriched more than thirteen years’ experience in Resourceful Specialist offering expertise in Technical Support, Service Sales, Customer service, Problem-solving, Data analysis and Quality assurance of complaints Handling in Medical devices healthcare field. Adept at quickly learning new technologies and processes for driving success. Proven track record of successfully managing multiple projects and developing innovative solutions. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Experienced in capital equipment Installation, Service, technical support and User end training for medical devices like Anesthesia workstations, ICU Ventilators, Patient Monitors, TMT, ECG Machines. Several years with GE Healthcare, Spacelabs Healthcare, BPL Medical technologies (now Medtronic) as an Senior MDR/Vigilance specialist for their Diabetic products. Was responsible for the promotion of new product applications, technical support, Service sales and onsite Product Repair support. Responsible for developing and maintaining the relationships with key customers, to develop and maintain a solid long term customer base.

• Received the Best support territory Engineer Award in customer handing when associated Global medical solutions (GE Healthcare vendor).

• Achieved the minimum 30% YOY growth in service revenue at Spacelabs Healthcare.

• Received Best performed quarter cash Award in GE healthcare due to quick ramp up in handling the complaints of multiproduct with/without technical training.

Overview

13
13
years of professional experience
8
8
years of post-secondary education
10
10
Certifications
4
4
Languages

Work History

Senior MDR/Vigilance Specialist

Medtronic
Hyderabad
07.2022 - Current

· Leading the team of 15 members in Quality and Productivity for diabetic process

· Handling the Internal audit Process for MEIC Diabetic process

· Maintained database systems to track and analyze operational data.

· Developed and updated tracking spreadsheets for process monitoring and reporting.

· Helped meet changing demands by recommending improvements to business systems or procedures.

· Conducted regular reviews of operations and identified areas for improvement.

· Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.

· Generated reports detailing findings and recommendations.

· Evaluated staff performance and provided coaching to address inefficiencies.

· Collected, arranged, and input information into database system.

· Evaluates incoming complaint information and maintains the record in the electronic database

· Performs follow up activities to obtain additional information

· Use and maintain database(s), provide analysis and trending data on all complaints

· Determines Reportability of complaints and submits Regulatory Reports to Government Agencies

· Identify and document appropriate complaint categories to assure trend accuracy within the complaint database

· Writes investigation summaries based on technical product analysis information provided;

· Ensures record documentation is maintained in a constant state of audit readiness per internal policies

· Liaison with groups who perform additional investigation and who prepare written record of investigation

· Providing basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations

· Reviews and interprets risk management documentation as it applies to the complaint event

· Interacting with multiple departments within Medtronic - RTG, such as Technical Services, Failure

· Investigation, R & D, Manufacturing and Engineering, as needed, during the course of complaint processing.

· Attended training programs to deepen professional skillset and assisted in training fellow store associates on existing and new training programs.

· Listened and responded to customer requests and forwarded necessary information to superiors.

· Followed all company policies and procedures to deliver quality work.

· Maintained current understanding of market conditions, compliance standards and best practices.

· Created and delivered presentations to internal and external stakeholders to showcase work.

· Monitored industry trends to adapt strategies accordingly.

· Analyzed marketing data and trends to identify opportunities for improvement.

  • Interpreted clients' needs and introduced services to fit specific requirements.

Product Surveillance Specialist

GE HealthCare
Bengaluru
09.2020 - 07.2022
  • Ensure timely handling of complaints and timely complaint investigation through complaint handling, process escalations and investigations, utilize clinical knowledge for adequate product safety assessment
  • Assist in Regulatory Audits
  • Identify complaints that require further evaluation according to global reporting requirements
  • Ensure appropriate criteria for closure of complaints are applied
  • Continuously Working to improve Complaint Handling Processes
  • Evaluate customer feedback & internal data for possible complaints
  • Evaluate incoming data & determine if it is sufficient to understand the nature of the complaint
  • Communicate with FSEs and Coordinators, Technical Service, Manufacturing, R&D, and Quality Assurance, to gather more data on complaints as needed.
  • Performs follow up activities to obtain additional information
  • Assist the Medical device Reporting team in collecting the required data for the initial assessment of reportability and Determines Reportability of complaints and submits relevant documents to the
  • Regulatory team
  • Assist in any request of information from Competent Authorities and Notified Body
  • Support the screening of complaints for reported serious injury/deaths and the assignment to investigators within stipulated time
  • Gather information required for review & closure of complaint record according to the complaint handling procedure (CHP )
  • Assess if the Risk assessment is covering the hazard in the complaint
  • Complete all needed records within the timeframe and with 100% accuracy
  • Support review of complaint records to warrant the quality of the record
  • Ensures record documentation is maintained in a constant state as good documentation practice and audit readiness per standard policies
  • Escalate to the CHU manager when necessary to determine the action to drive timely and effective resolution of the complaint and writes investigation summaries based on technical product analysis information provided
  • Identified and resolved areas of risk and exposure and recommended solutions and improvements to access control systems and video surveillance systems
  • Reported any incidents immediately to local law enforcement

Global Technical Support Engineer-Penlon

BPL Medical Technologies Pvt Ltd
Bengaluru
11.2017 - 09.2020
  • Handled of Complaints, Vigilance and Post Market Surveillance (PMS) including handling of Provision of Technical Support and Service, Health and Safety to Customers and Distributors:- # Logging and initial coordination of investigations required for complaints in CRM Database
  • Responsible for ensuring that the complaints systems service relevant stages and actions are completed
  • Informing QA & GTS Managers of any impending problems indicated by trends in the warranty database and complaints that meet the reporting criteria.
  • Technical Support to the Sales Representatives and Penlon/BPL Service Engineers
  • To ensure compliance with the company Health and Safety Policy and further policies, actions or requirements arising.
  • Explained technical information in clear terms to non-technical individuals to promote better understanding.
  • Responded to support requests from end-users and patiently walked individuals through basic troubleshooting tasks.
  • Assessed system hardware and software and suggested modifications to reduce lag time and improve overall speed.
  • Served as primary point of contact for support relating to owned solutions and products.
  • Worked directly with clients in rollout and post-rollout stages to train and support new applications and systems.
  • Delivered Tier-3 support and SME input to internal and external customers.
  • Performed root cause analysis of reported issues to enact corrections.
  • Traveled with sales and Service engineers on customer site visits to respond to specific technical questions.
  • Documented faults and bugs for referral to development staff for use in updates.
  • Gathered trend data from customer calls and interactions.
  • Explained technical information in clear terms to promote better understanding for non-technical users.
  • Met with team personnel to share details of discovered issues and recurrent custom complaints.
  • Provided guidance on installing and integrating new hardware components and software to remote clients.
  • Researched new tactics to better hone responses and shorten remediation times and Maintained response times to support business continuity.
  • Designed tailored engineering solutions for customers based upon key requirements.
  • Advised senior personnel on potential process improvements to increase support quality and expedite ticket fulfillment.
  • Suggested software and hardware modifications to reduce lag time and improve overall speed.
  • Communicated with stakeholders to share critical technical information and deliver project updates.
  • Updated and maintained current customer support database.
  • Resolving problems encountered with any Penlon Product and Ensure all corrective/preventative measures are implemented
  • Aiding the customer through fault diagnosis, test elimination, to find the faulty component/part so as to negate the need for the return of equipment under warranty
  • Provide training support to untrained distributors on how to calibrate and perform fault diagnosis on Penlon products Technical support to training
  • Reserve trainer for customer training of Penlon product
  • Audit of distributors to ensure that their training is up to date and to ensure the correct levels of spare parts are stocked
  • Promote the sale of parts and training to distributors and end-users
  • To portray at all times a professional and ethical image
  • Promoting the quality within the organization
  • Complete tasks as assigned by Manager in a timely manner
  • Served as primary point of contact for support relating to owned solutions and products
  • Responded to support requests from end-users and patiently walked individuals through basic troubleshooting tasks
  • Explained technical information in clear terms to non-technical individuals to promote better understanding
  • Traveled with sales engineers on customer site visits to respond to specific technical questions
  • Updated and maintained current customer support database
  • Maintained response times to support business continuity
  • Researched new tactics to better hone responses and shorten remediation times
  • Delivered Tier-3 support and SME input to internal and external customers
  • Worked directly with clients in rollout and post-rollout stages to train and support new applications and systems
  • Designed tailored engineering solutions for customers based upon key requirements
  • Suggested software and hardware modifications to reduce lag time and improve overall speed
  • Provided guidance on installing and integrating new hardware components and software to remote clients
  • Advised senior personnel on potential process improvements to increase support quality and expedite ticket fulfillment
  • Explained technical information in clear terms to promote better understanding for non-technical users
  • Communicated with stakeholders to share critical technical information and deliver project updates
  • Gathered trend data from customer calls and interactions
  • Performed root cause analysis of reported issues to enact corrections
  • Documented faults and bugs for referral to development staff for use in updates
  • Met with team personnel to share details of discovered issues and recurrent custom complaints

Customer Service Engineer- South and West India

Spacelabs Healthcare
Bengaluru
03.2015 - 11.2017
  • Handled the assigned territory of six engineers to plan and execute Installation of equipment like Patient Monitors, Anesthesia Workstations
  • Communicated with vendors regarding backorder availability, future inventory, and special orders.
  • Developed and implemented preventive maintenance procedures.
  • Answered product and service questions, suggesting other offerings to attract potential customers.
  • Provided primary customer support to internal and external customers.
  • Helped streamline repair processes and update procedures for support action consistency.
  • Monitored system performance to identify potential issues.
  • Diagnosed and troubleshot hardware, software and network issues.
  • Generated reports to track performance and analyze trends.
  • Created user accounts and assigned permissions.
  • Responded to customer inquiries and provided technical assistance over phone and in person.
  • Researched and identified solutions to technical problems.
  • Collaborated with vendors to locate replacement components and resolve advanced problems.
  • Broke down and evaluated user problems, using test scripts, personal expertise, and probing questions.
  • Configured and tested new software and hardware.
  • Major focus is attending the various customer issues and escalations
  • Managing & handling effective relationships with customers on after sales issues
  • Organizing events and customer meets to explaining them the product details
  • Regular field visit to Hospitals for Service issues and PMS and application training on products
  • Ensuring excellent service delivery to customers
  • Collecting AMC & CMC Contracts and handling in payment collections for private and Government organizations within time manner for AMC, CMC and accessories and spares supplied against PO
  • Answered product and service questions, suggesting other offerings to attract potential customers
  • Provided primary customer support to internal and external customers
  • Communicated with vendors regarding backorder availability, future inventory, and special orders
  • Recommended products to customers, thoroughly explaining details
  • Collaborated with vendors to locate replacement components and resolve advanced problems
  • Offered assistance in implementing and developing training programs
  • Tested new software and hardware prior to deployment
  • Configured and tested new software and hardware
  • Generated reports to track performance and analyze trends
  • Responded to customer inquiries and provided technical assistance over phone and in person
  • Developed and implemented preventive maintenance procedures
  • Configured hardware, devices, and software to set up work stations for employees
  • Diagnosed and troubleshot hardware, software and network issues
  • Researched and identified solutions to technical problems
  • Helped streamline repair processes and update procedures for support action consistency
  • Created user accounts and assigned permissions
  • Monitored system performance to identify potential issues

Customer Support Service Engineer

Global Medical Systems(GE HealthCare)
Bengaluru
07.2010 - 03.2015
  • Ensured to Installing and maintaining large number of ICU Ventilators, Anesthesia workstations, monitors, Warmers, Photo therapies, Incubators, Pulse oximeters
  • Ensuring to provide the user training on Do’s and Don’ts to clean and sterilize for auto clavable parts
  • Planning and Implementation of products promotion and marketing strategies
  • Optimize quality of service, Business growth and customer satisfaction.
  • Served as primary point of contact for support relating to owned solutions and products.
  • Explained technical information in clear terms to non-technical individuals to promote better understanding.
  • Responded to support requests from end-users and patiently walked individuals through basic troubleshooting tasks.
  • Suggested software and hardware modifications to reduce lag time and improve overall speed.
  • Gathered trend data from customer calls and interactions.
  • Worked directly with clients in rollout and post-rollout stages to train and support new applications and systems.
  • Traveled with sales engineers on customer site visits to respond to specific technical questions.
  • Maintained response times to support business continuity.
  • Advised senior personnel on potential process improvements to increase support quality and expedite ticket fulfillment.
  • Explained technical information in clear terms to promote better understanding for non-technical users.
  • Delivered Tier-3 support and SME input to internal and external customers.
  • Researched new tactics to better hone responses and shorten remediation times.
  • Communicated with stakeholders to share critical technical information and deliver project updates.
  • Documented faults and bugs for referral to development staff for use in updates.
  • Provided guidance on installing and integrating new hardware components and software to remote clients.
  • Designed tailored engineering solutions for customers based upon key requirements.
  • Updated and maintained current customer support database.
  • Performed root cause analysis of reported issues to enact corrections.
  • Met with team personnel to share details of discovered issues and recurrent custom complaints.
  • Expertise in modifications/alterations/improvisation to instruments or devices to ensure proper function

Education

Bachelor's degree - Electrical and Electronics Engineering

Visvesvaraya Technological University, Ranebennur, Karnataka
01.2006 - 04.2010

High School Diploma, PCMB -

DVS Composite PU College, Shivamogga,Karnataka
01.2004 - 04.2006

Diploma -

SKN Model English High School, Shivamogga, Karnataka
01.2003 - 04.2004

Skills

Teamwork and Collaboration

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Certification

Risk Management

Software

Use of Software tools such as Smartsolve, PEGA , Oracle and SAP

Timeline

Senior MDR/Vigilance Specialist - Medtronic
07.2022 - Current
Product Surveillance Specialist - GE HealthCare
09.2020 - 07.2022
Global Technical Support Engineer-Penlon - BPL Medical Technologies Pvt Ltd
11.2017 - 09.2020
Customer Service Engineer- South and West India - Spacelabs Healthcare
03.2015 - 11.2017
Customer Support Service Engineer - Global Medical Systems(GE HealthCare)
07.2010 - 03.2015
Visvesvaraya Technological University - Bachelor's degree, Electrical and Electronics Engineering
01.2006 - 04.2010
DVS Composite PU College - High School Diploma, PCMB,
01.2004 - 04.2006
SKN Model English High School - Diploma,
01.2003 - 04.2004
Anoop PrahalladacaharSenior MDR/Vigilance Specialist