VIKRAMSINGH. H. DANGE

• Management of complete operations of Medical devices team for Cebu city, Philippines and Kolkata, India with a span of 250+ FTE's & multiple business units like CT, MRI, Sleep & respiratory care product for complaints management & vigilance reporting (Initiation, Evaluation investigation, Good faith efforts, MDR's, MIR's etc.)
• Managing of Customer service voice complaints team of 60+ FTEs
• Cultivate strong business relationships with customer to drive business smoothly as single point of contact
• Monitoring, evaluation & propose mitigation strategies surrounding risk to SLA's & project deliverables
• Oversee daily, weekly and monthly generation of project metrics (Productivity targets, SLA & KPI's)
• Accountable for project financials to drive healthy gross profit & revenue margins
• Prepare and lead operational & governance calls with clients (Weekly & Monthly business reviews)
• Coordination with other functional support teams for any project related issues
• Manage all the SOW and contracts renewals & negotiate with clients for increase in scope of work to drive health revenue and margins
• Strategic planning for proper staff and training
• Managing location audits internal and external (CMS & ISO 13485)
• Capacity planning & resource management

Key Achievements: Exponential growth of the project to 1000 FTE's from 30 FTE's, Built AI tool for enhanced training and learning, Best operations manager award, Best proactive deal, Best operating margin account award in all LOB's. Silver metal account with 25 Million dollar business. ISO 13485 external audit with no audit findings and observations.

• Onsite deputy manager of Cebu city for new project
• Transition of new logo during pandemic with new clients & team of 30 FTE's
• Responsible in monitoring training and qualification of all team members for complaints handling backlog project
• Daily & weekly review meetings with clients and internal stakeholders
• Monitoring of daily productivity & quality
• Managing multiple business units (CT, X-ray, MRI) complaints handling customers

Key achievements: Completed all the backlogs for the business units before deadline leading to more confidence of the customers and more addition of 80 FTE's for North America market.

• Management of complete operations of Medical devices team at Airoli Mumbai location as location head
• Cultivate strong business relationships with customer to drive business smoothly as single point of contact
• Administration of daily operations to ensure all policies are adhered
• Monitoring of daily SLA, productivity and quality for the employees
• Strategic planning for proper staff and training
• Managing location audits internal and external (CMS & ISO 13485)
• Capacity planning & resource management

• Handling Post Marketing Surveillance team (PMS) of 85 team members for ICSR reporting of Drugs
• Workload management of overall group located in Mumbai & Kolkata
• Monthly Business review
• Management of SLA and KPI's for PMS team
• Reporting of SLA & KPI's to higher management
• Resource & attrition management

Key Achievements: Developed tool for case allocation reducing manual efforts, Six sigma certified

• Handling Team of 28 FTE's
• Daily case prioritization and allocation
• Preparation of weekly and monthly deck for operations
• Handling daily production and quality for team
• Weekly client calls and meetings
• Management of SLA metrics
• People management, monthly one on one meeting with associates for their performance, goal settings quarterly for associates, leave planning
• Strategic planning for ad hoc activities from client.

• Job Role and responsibility
• Software testing done of ARISg 6.6 for new client
• Design made for all major functionalities of ARISg 6.6
• 42 Scripts designed
• Dry run and validation done for all 42 scripts.

• Processing all kinds of ICSR cases
• Quality reviewer for all spontaneous and clinical cases
• Processing of Product Technical Complaint (PTC) cases as a Medical device officer (MDO)
• Communicating with client weekly in telephonic conference to resolve any issues or difficulties faced in processing PTC cases
• Written sample PBRER on pilot project of aggregate writing.

Achievements:

• From November 2013 to February 2013, was a captain for 6 people team for a 4 months critical project with team name as “Spartans”. I had successfully handled and completed the project before 2 days of client's deadline, for which my team got first prize and was appreciated by all management team as well as by client.
• From March 2013 to May 2013, was assigned a 2 months project with 5 new associates as part of my team to complete 15000 PTC cases in 2 months time. My team has completed all 15000 cases on time. Individually I have completed 1200 cases as well as managed the 5 new associate's team in two months which was appreciated by client as well as by management team.
• Company won the Aggregate writing project and client accepted the sample PEBRER written by me in a very stringent timelines of 7 days. It was appreciated by client as well as by all Cognizant management team for my skills and hard work in writing pilot PBRER.

• Drug safety ICSR specialist
• Initial assessment (triage) and case level review of all serious adverse event (SAEs) and Spontaneous reports received in compliance with SOPs and regulatory requirements
• Duplicate searching of cases and check whether the case is valid
• Data entry, case processing for Clinical, Spontaneous, Solicited case and coding in
• MedDRA of SAEs and adverse events (Aes) determination of labeling, report ability, and
• Completing cases within required timelines
• Maintain accuracy, consistency and completeness of safety database and tracking log
• Communication with SME and in house OPS physician for any queries regarding the case
• Generate queries for the collection of additional information for AEs and SAEs
• Assists with the development of data entry conventions to ensure consistency across database users and products
• SAE Reconciliation for more than 1 year
• Biweekly client call for SAE reconciliation updates and queries
• Back up Team lead with the team for more than 1 year

Achievements:

• Handled short time (3 to 4) projects with a team of 16 associates, in a very stringent timelines to complete all cases
• All projects I had successfully managed and completed on time
• I was highly appreciated by all management as well as by client
• For more than 1 year, was the only person to handle SAE Reconciliation process of my project
• My responsibility was to reconcile all the data with ARISG database and clinical database
• Back up TL Activities: Was handling team of 16 associates and managing them as a backup TL within team
• Providing plan of action for the day, case distribution according to regulatory and Licensee partner timeline and get closed it within timelines, preparing various trackers as per client requirement, communicating with clients.