Raj Mahanty

Work History

Manager, Safety Systems

Fortrea Development India Pvt Ltd (Formerly known as Labcorp Drug Development India Private Limited)

07.2023 - Current

Conducted technical impact analysis and estimated business value to evaluate proposed project ideas and software changes, contributing to decision-making
Independently led meetings and developed IT system strategy, compliance management, periodic system evaluation
Initiated discussions with business stakeholders to understand requirements, documented user needs
Carried out line management responsibilities for assigned staff, including performance management
Represented the Systems team at internal project team meetings, client meetings, and audits
Supervised the day-to-day usage, operation, and maintenance of computer systems, providing user training and support as needed
Managed contracts and services from suppliers and vendors
Managed major incidents, including system transitions and change management
Demonstrated understanding of ITIL and experience in change management, configuration management, release management, and incident/ problem management
Maintained professional, organized, and safe environment for employees and patrons.
Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
Cross-trained existing employees to maximize team agility and performance.
Maximized performance by monitoring daily activities and mentoring team members.
Onboarded new employees with training and new hire documentation.
Monitored and analyzed business performance to identify areas of improvement and make necessary adjustments.
Improved safety procedures to create safe working conditions for workers.
Developed and maintained relationships with customers and suppliers through account development.
Controlled costs to keep business operating within budget and increase profits.
Planned and budgeted accurately to provide business with resources needed to operate smoothly.
Conducted safety training and education to employees to increase awareness of safety hazards and empower employees to work safely.
Investigated accidents and incidents to determine root causes and develop corrective actions to address underlying issues.
Liaised with management and employees enable smooth communication regarding safety procedures.
Assessed value of safety programs to apply modifications and improvements and achieve targeted goals.
Stayed updated with new safety system practices, methods, tools, regulatory practices, and industry trends to foster departmental growth
Possessed substantial experience in all aspects of pharmacovigilance operations as a techno-functional consultant in Oracle Argus Safety (Pharmacovigilance & Drug Safety domain)
Extensive knowledge and experience in configuring Argus Interchange (ESM) for importing/exporting E2B files from partners
Excellent at preparing and executing operational and performance qualification scripts (OQ and PQ) to validate Argus Application according to client requirements
Resourceful in maintaining relationships with clients and vendors to achieve high-quality deliverables
Proficient in scope identification, requirement gathering, test case development, and change management
Well-organized with a proven track record of self-motivation, creativity, and initiative in achieving personal and corporate goals
Managed and motivated employees to be productive and engaged in work.
Accomplished multiple tasks within established timeframes.

Manager

Labcorp Drug development

12.2022 - 06.2023

Evaluate proposed project ideas /software changes through technical impact analysis and estimated business value to contribute to decision-making
Independently driving meetings and developing the IT system strategy
Compliance management, periodic System Evaluation, reviewing Enterprise
Architecture of the system
Initiate discussions with business stakeholders to understand business requirements, document user requirements and ensure requirements are delivered on time and in collaboration with Tech partner
Support with change management and training of the systems, as needed
Subject matter expert, looking for ways to improve compliance, quality and efficient
Lead critical team projects, responsible for managing team's workload
Monitors staff projects quality, timelines and budgets to foresee and correct issues and assure project expectations are met
Cross-trained existing employees to maximize team agility and performance.
Maximized performance by monitoring daily activities and mentoring team members.
Onboarded new employees with training and new hire documentation.
Monitored and analyzed business performance to identify areas of improvement and make necessary adjustments.
Communicated clearly with employees, suppliers and stakeholders to keep everyone on same page and working toward established business goals.
Developed and implemented business strategies to achieve business goals and stay competitive.
Maintained professional demeanor by staying calm when addressing unhappy or angry customers.
Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
Established performance goals for employees and provided feedback on methods for reaching those milestones.
Developed detailed plans based on broad guidance and direction.
Leveraged data and analytics to make informed decisions and drive business improvements.
Planned, created, tested and deployed system life cycle methodology to produce high quality systems to meet and exceed customer expectations.
Streamlined and monitored quality programs to alleviate overdue compliance activities.
Effectively communicate the status of projects to line management and project managers
Manages resources within team: new hires, terminations, transfers, and contractors
Carry out line management responsibilities for assigned staff, including
Performance Management and Development activities, disciplinary procedures and administrative activities
Helps encourage staff career growth and development
Act as the lead overseeing technical planning for increasingly complex projects including global and multiple study projects and electronic submissions
Representing Systems team at internal project team meetings, client meetings and audits
Contribute to ongoing improvement of programming processes, methodology and documentation
Facilitate advanced technical expertise, share knowledge at department meetings
Keeps abreast of new Safety system practices, methods and tools, regulatory practices, and industry trends to stimulate departmental growth
Any other duties as assigned by management.
Managed and motivated employees to be productive and engaged in work.
Accomplished multiple tasks within established timeframes.

Associate Manager

Covance

05.2021 - 12.2022

Monitors staff projects quality, timelines and budgets to foresee and correct issues and assure project expectations are met
Help staff identify resource or scope of work changes
Effectively communicate the status of projects to line management and project managers
Manages discretionary expenses and spending within team in order to meet budget
Work closely with leads to ensure that staff resources are used efficiently, and team is well utilized
Manages resources within team: new hires, terminations, transfers, and contractors
Carry out line management responsibilities for assigned staff, including
Performance Management and Development activities, disciplinary procedures and administrative activities
Helps encourage staff career growth and development
Provides system support and technical support to team members
Oversaw training and onboarding process for all newly hired employees within Safety System team.
Helped with planning schedules and delegating assignments to meet coverage and service demands.
Offered hands-on assistance to customers, assessing needs, and maintaining current knowledge of consumer preferences.
Act as the lead overseeing technical planning for increasingly complex projects including global and multiple study projects and electronic submissions
Representing Systems team at internal project team meetings, client meetings and audits
Contribute to ongoing improvement of programming processes, methodology and documentation
Facilitate advanced technical expertise, share knowledge at department meetings
Keeps abreast of new Safety system practices, methods and tools, regulatory practices, and industry trends to stimulate departmental growth
Set and enforced performance and service standards to keep consistent, high-quality environment devoted to customer satisfaction.
Coordinated resources from stakeholders and mapped out project deliverables.
Mentored team members to enhance professional development and accountability in workplace.
Increased employee performance and job satisfaction to strengthen retention and engagement.
Created employee schedules to align coverage with forecasted demands.

Senior System Administrator,Assistant Manager

Covance

09.2019 - 05.2021

Conduct project specific configurations in Safety systems
Maintain and document system configuration based on initial requirements and any subsequent changes
Conduct project specific configurations in Safety systems
Implementation of custom E2B profile as per business requirement for BFC, R2-R3 XML format for PMDA, CNDA, FDA combination products
Development of whole new E2B profile of 250 new DTD Element for EU-MIR reporting
Conduct project specific configurations in Safety systems
Support and Enhancement for drug safety products such Oracle Argus Safety
Empirica Signal management.
Supervised day-to-day operations to meet performance, quality and service expectations.
Offered hands-on assistance to customers, assessing needs, and maintaining current knowledge of consumer preferences.
Generated repeat business through exceptional customer service and responded to customer concerns with friendly and knowledgeable service.
Mentored team members to enhance professional development and accountability in workplace.
Deployment of Web application on client servers
Worked with all top 5 pharma companies
Conduct project specific configurations in Safety systems
Worked on data transposition module of Argus 8.x upgrade I.e analysis of new UI fields introduced in Argus 8.2 versus the existing UI fields in Argus 7.x
Evaluate proposed project ideas / software changes through technical impact analysis and estimated business value to contribute to decision-making
Provide overall guidance and strategize use of standard safety systems front- end reporting; including use of advanced conditions and Standard MedDRA
Queries (SMQ), Develop and document standard and ad hoc reports from the safety systems
Create front end advanced conditions including query sets and generate custom reports from the Argus database
Conduct routine and ad hoc data extraction (i.e
PSURs, DSURs, 6- monthly listings)
Ensure that search algorithms are clearly and consistently documented
Support and educate to end users and sponsors, if applicable
Receive and respond user questions/issues and contribute to resolution of issues collaborating with technical support
Collaborate with DDSS training liaison in development of safety system specific training modules
Manage safety system access requests (internal and external)
Resolved issues and escalated problems with knowledgeable support and quality service.
Maintained flexible schedule and responded to after-hours and weekend emergencies.

Senior Product support tech Advisor

IQVIA

04.2018 - 09.2019

Work as a shift lead and handle the designated shift
Perform quality review for the team every quarter
Host the daily operation calls and ensure all current issues have the latest status
Communicate IT issues to business units at various levels of seniority
Manage and coordinate the implementation of internal, external and off-the- shelf business applications with all IT and business groups
Coordinate with internal and external service providers in the area of incident, problem, and change management, capacity planning and troubleshooting, representing the interests of supported business groups
Manage and support vendor contracts to established service level agreements
Work closely with customers to identify business requirements and opportunities in relation to IT systems and services
Provide first line assistance to end users of our Global Life-cycle Safety
Platform ensuring accurate logging and tracking of requests
Triaging of tickets and assigning to the respective team to help resolve the issue.
Collaborated with internal team members and customer representatives to clarify relationship of business and project goals and obtain enhanced perspective of development process.
Worked with development team to define and implement customer change requests to enhance product functionality.
Attended weekly development team meetings and assisted in identification and resolution of issues to maintain timeline and budget integrity.
Assisted development leads in definition of process flows, relative task priorities and business value measurement parameters.
Studied multi-faceted development issues and suggested solutions to satisfy project goals and adhere to timeline and budget parameters.
Supported development team in generation of technical requirements and product documentation to achieve process commonality.
Contributed to creation and implementation of technical requirements and specifications to establish common foundation for application development.

Oracle Argus Technical Consultant

IQVIA

10.2016 - 04.2018

Strong knowledge of ARGUS Safety application
Good knowledge of PV safety systems
Strong knowledge of working with EU/FDA/PMDA regulated environment
Strong knowledge of Argus Database
Knowledge of Database management system in the SQL
PLUS and PL/SQL
Configuration of Code List, Site, User Group Creation, User creation and
Accessibility, Products, Licenses, Studies, System Numbering, System
Configuration and Work-flow design
Good understanding of XML-E2B transmissions
Configuring ESM Service, AG Service, SMTP Server
Resolving L1/L2/L3 issues related to the functionality of the Oracle Argus Safety application
Investigated system issues and implemented resolutions to reduce downtime.
Recommended technology upgrades to improve client security.
Analyzed client business processes to propose optimal software applications for unique requirements.
Perform IQ, OQ and PQ validation for Oracle Argus Safety
Well versed with creation and modification of reporting rules as per business requirement
Experience of upgrading MEDDRA, JDRUG, WHOSRUG, MR DATA LOAD
Creation of community and routing IDs on AXWAY using TLS1.2 and TLS 1.0
Product support tech advisor
Ensure compliance with customers' Service Level Agreements with respect to incident and request completion
Assist in the generation of standard ad hoc query reports as required
Troubleshoot errors associated with case reporting and E2B
Close liaison with second and third level teams and external vendors to work through complex support issues
Ensures adherence to relevant support SOPs and WIs that relate to the provision of end user support and can support audits as required
Implement, maintain and continually seek to improve procedures and processes used by the team
Interact with software vendors, infrastructure services, and/or applications development to quickly restore system issues having a wide impact
Play a key role in the communication cascade to customers, business partners and stakeholders
Coordinate with internal and external service providers in the area of incident, problem, and change management
Ability to establish effective working relationships with all customers, partners and co-workers
McAfee DAM Monitoring

Site Support Engineer

Quintiles

10.2013 - 10.2016

Troubleshoot errors associated with case reporting and E2B transmission
Collaborated with vendors to locate replacement components and resolve advanced problems.
Implemented technical solutions to solve customer issues and increase satisfaction.
Monitored systems in operation and quickly troubleshot errors.
Provided Continuous support to Business users in 24/7 uptime environment, often working double shifts to accommodate time zones.
Collaborated with outside departments to implement system-wide improvements.
Patched software and installed new versions to eliminate security problems and protect data.
Maintained servers and systems to keep networks fully operational during peak periods.
Created user accounts and assigned permissions.
Monitored system performance to identify potential issues.
Close liaison with second and third level teams and external vendors to work through complex support issues
Ensures adherence to relevant support SOPs and WIs that relate to the provision of end user support and can support audits as required
Implement, maintain and continually seek to improve procedures and processes used by the team
With guidance can assist in the management and coordination of system deployments
Interact with software vendors, infrastructure services, and/or applications development to quickly restore system issues having a wide impact
Play a key role in the communication cascade to customers, business partners and stakeholders
Coordinate with internal and external service providers in the area of incident, problem, and change management
Ability to establish effective working relationships with all customers, partners and co-workers
Perform other duties as directed

PV Safety Analyst

Quintiles

02.2010 - 10.2013

Monitored workplace activities to determine compliance with safety regulations and standards.
Conducted safety audits and inspections to identify workplace hazards and deficiencies.
Investigated incidents, determining root causes and implementing corrective actions.
Developed and implemented safety policies and procedures to promote workplace safety.
Handling key issues (Incident management)
Log and track incoming request
Entering protocols into Safety database
Handling E2B Issues
Helping teams with mailbox related issues and accesses
Completing assigned tickets within given SLA
Perform application testing
Participate in team meetings/ facilitate and sending meeting minutes
Perform database searches
Contact external software vendors as and when required
Skilled at working independently and collaboratively in a team environment.
Proven ability to learn quickly and adapt to new situations.
Worked well in a team setting, providing support and guidance.
Proved successful working within tight deadlines and a fast-paced environment.

Senior Process Executive, Technical Support Engineer

Infosys

07.2007 - 02.2010

Training and Documentation: Train and onboard new team members, ensuring they are equipped with the necessary knowledge and skills to provide effective technical support
Create and maintain process documents to ensure standardized workflows and knowledge sharing
Technical Problem Solving: Interact with UK engineers to troubleshoot and resolve customer-related technical problems
Utilize your technical expertise to test UK phone lines and provide solutions to local engineers, ensuring prompt issue resolution
Incident and Request Management: Work on assigned incidents and requests, prioritizing and resolving technical issues within agreed upon service level agreements
Collaborate with internal and external service providers to ensure efficient incident, problem, and change management processes
User Acceptance Testing: Perform user acceptance testing of new systems, applications, or software releases to ensure functionality, reliability, and adherence to client requirements
Six Sigma Projects: Identify and initiate various Six Sigma projects with a focus on improving process efficiency, customer satisfaction, and operational effectiveness
Oversaw change management duties during new business process onboarding, reducing productivity interruptions.
Supervised meetings to maintain interdisciplinary communication of process weaknesses and performance.
Drive the implementation of process enhancements and monitor their impact on key performance indicators
Critical Escalation Handling: Handle critical escalations from customers, addressing their concerns promptly and effectively
Attend client calls to understand and resolve technical issues, ensuring customer satisfaction and maintaining strong client relationships
Plan and Process Implementation: Actively participate in the development and implementation of new plans and processes, ensuring smooth transitions and minimal disruption to service delivery
Collaborate with cross-functional teams to ensure effective communication and change management
Local Technical Issue Resolution: Troubleshoot and resolve technical problems efficiently to minimize customer downtime and ensure smooth operations.
Collaborated with peers to measure ongoing process performance, enacting changes based on historical data.

Summary

Overview

Work History

Manager, Safety Systems

Manager

Associate Manager

Senior System Administrator,Assistant Manager

Senior Product support tech Advisor

Oracle Argus Technical Consultant

Site Support Engineer

PV Safety Analyst

Senior Process Executive, Technical Support Engineer

Education

MBA - Health/Health Care Administration/Management

Bachelor of Science - Zoology/Animal Biology

Certificate in Computing (CIC), Computer Science -

High School Diploma -

Science

Skills

Websites

Certification

Languages

Work Availability

Timeline

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