Websites
Summary
Overview
Work History
Certification
Education
Skills
Accomplishments
Personal Information
Disclaimer
Timeline
Deepak Gupta

Deepak Gupta

Associate Director, RA/PV/QC Strategic Sourcing & Vendor Management
Kalyan

Websites

Summary

Pharmacy graduate and PMP certified with more than 15 years of experience in the currently working as Associate director (Strategic sourcing & vendor Management) and have experience in Operation & Delivery management, Pharmacovigilance including Aggregate Reports (ICSR, PSUR, PBRER, AR, ER, APQR & PADER), Clinical Research, and licensing agreement. Proven project management abilities with capacity to design, plan and implement ideas from conception through completion, able to manage multiple responsibilities without compromise to detail or quality, Outstanding interpersonal skills equally comfortably communicating one on one or addressing large audience.

Overview

15
15
years of professional experience
6
6
years of post-secondary education
1
1
Certification

Work History

Associate Director

Organon International
Mumbai
8 2021 - Current
  • Managing various suppliers across RA/PV/QC category
  • Build and manage processes and facilitating network of resources to support partners ability to execute on sourced scope of work
  • Manage regulatory affairs and clinical safety sourced activities to support efficient, on-time execution of regulatory and clinical safety submissions
  • Actively facilitate (and escalation as necessary) of process issues related to delivery of high- quality, on time materials
  • Collaborate with internal teams and external parties to ensure best possible delivery of sourced submission work through clearly defined objectives and actively managing and tracking overall performance (via metrics) of assigned vendors
  • This includes providing regular feedback to management on performance of vendors, ensuring deliverables are met and performance issues are identified, managed, and rectified, and providing regular feedback to vendor management and internal teams on performance issues
  • Actively collaborate with and providing guidance to vendors to assure new capabilities and services are developed and existing capabilities and processes are assessed and improved (on ongoing basis) and assuring consistent application of roles and processes across projects
  • Support of annual business planning and analysis, and proposal of annual financial plan related to external partner expenditures
  • Managing processes and connections between the external partner and the various stakeholders within R&D including Global Regulatory Affairs and Pharmacovigilance functional teams and Procurement to ensure that we are efficiently and effectively delivering high quality regulatory and safety submissions on time globally
  • Worked flexible hours across night, weekend, and holiday shifts as per requirement
  • Proved successful working within tight deadlines and fast-paced environment
  • Proven ability to develop and implement creative solutions to complex problems
  • Worked well in team setting, providing support and guidance
  • Established strong relationships with key industry partners, creating mutually beneficial opportunities for growth and collaboration
  • Reduced operational costs by identifying inefficiencies and implementing cost-saving measures in various departments
  • Developed competitive pricing strategies based on extensive market research data analysis.

Service Delivery Manager/Team Manager

Cognizant Technology Solution Pvt. Ltd.
Mumbai
02.2014 - 08.2021
  • Handled team of 50 people involved in Aggregate reports (Authoring and quality review) along with mentoring and training of PSUR team
  • End to end preparation of aggregate safety reports including addressing health authority reports
  • Leading/authoring Aggregate Reports (mainly PBRER and addendum statements) right from maintaining global reporting calendar to collating information from all pertinent stakeholders /departments for sections, authoring, review safety reports and submitting finalized document to regulatory authority.
  • Assisted in other safety periodic reports like APQR, PADER, ACO and Expert Report
  • Conducting meetings to review internal project/task status and closely monitoring team performance against client Service Level Agreements
  • Lead/guide team in process improvement initiatives in agreement with client
  • Prepare quality and trend analysis reports on monthly and quarterly basis for internal operation stakeholder and client
  • Client interfacing: Extensively interacting with the client from the time took over the Aggregate Reporting Project from the perspective of report related queries, training, productivity numbers, quality analysis, and audit requirements as well as RCA-CAPA discussions and finalizations
  • During this time, have managed to develop a very strong rapport with the client, which is extremely valuable from the perspective of maintaining long-term relationship and goodwill
  • Involved in Project Billing, Audit & Inspections, RCA/CAPA, Recruitment and Leave Management etc
  • Established a culture of continuous improvement, encouraging team members to share ideas for process enhancements
  • Coordinated with multiple departments to ensure seamless service delivery across all touchpoints
  • Served as primary interface for onboarding new personnel, providing educational resources on service delivery policies and establishing scheduling calendars
  • Maintained up-to-date knowledge of industry trends, incorporating best practices into internal procedures for ongoing success
  • Managed vendor relations proactively, negotiating contracts beneficially for both parties involved
  • Improved service quality, addressing client concerns promptly and professionally
  • Developed training programs to enhance employee skills and boost overall productivity levels
  • Optimized resource utilization, identifying opportunities for cost reduction and efficiency improvements
  • Applied effective time management techniques to meet tight deadlines
  • Demonstrated leadership skills in managing projects from concept to completion
  • Developed a high-performing team by recruiting top talent, providing ongoing training, and fostering a positive work environment
  • Streamlined communication channels for increased efficiency in project execution and decision-making processes
  • Established team priorities, maintained schedules and monitored performance
  • Enhanced team productivity by implementing efficient task delegation and time management strategies
  • Collaborated with cross-functional departments to drive cohesive efforts towards common goals and objectives
  • Achieved project deadlines consistently by closely monitoring progress and proactively addressing any potential roadblocks
  • Administered monthly and annual reviews to direct reports and set clear and measurable goals, action plans, and follow-up procedures
  • Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement
  • Reduced employee turnover rates with targeted retention initiatives, including competitive compensation packages and career advancement opportunities.

Data Analyst/Team Lead (ICSR Quality Review Lead)

Cognizant Technology Solution Pvt. Ltd.
Mumbai / Buenos Aires
08.2011 - 01.2014
  • Handled team of 80 people involved in ICSR QC & Assessment and special projects of ICSR case processing
  • Plan, organize, and manage daily work to meet Service Level Agreements and deliverables
  • Ensuring accuracy of daily activities performed by team and complying with internal timelines
  • Conducting regular team and client meeting for team's improvement in productivity and project quality compliance, and process harmonization
  • Review case quality processed by team members including correct product and event coding, narrative writing, labeling and causality
  • Collaborated with cross-functional teams to identify root causes of quality issues and implement corrective actions
  • Resolved customer complaints effectively by promptly addressing identified issues and implementing preventive measures to avoid future occurrences
  • Performed root cause analysis to identify and resolve defects, improving quality standards
  • Fostered strong working relationship with external auditors, ensuring efficient completion of quality management system reviews and seamless integration of recommended improvements
  • Implemented continuous improvement initiatives that led to significant reductions in defect rates
  • Preparing & sharing quality reports, RCA/CAPA with process and operational team on a regular basis.

Jr. Data Analyst (Safety Processing Expert)

Cognizant Technology Solutions Ltd.
Mumbai
07.2010 - 07.2011
  • Performed activities such as book-in and processing of different types of case reports such as Post Marketing Surveillance (PMS), Hospital discharge summaries, Spontaneous and Literature reports
  • Accurate data entry and coding of adverse event reports, and evaluation of non-expeditable reports within well-defined timeframes, in compliance with SOPs and regulatory requirements
  • Medical judgment and scientific assessment, Narrative, Labeling and Causality (Naranjo Assessment), Relatedness/Expectedness assessment
  • Continually updated professional knowledge through participation in relevant training programs ensuring adherence to best practices
  • Paid attention to detail while completing assignments
  • Gained extensive knowledge in data entry, analysis and reporting.

Research Analyst / Scientific Writer

WNS Global Services Ltd.
Mumbai
12.2008 - 07.2010
  • Created and maintained database to store research data
  • Managed time efficiently in order to complete all tasks within deadlines
  • Developing Intelligence Reports: Making quarterly and yearly intelligence reports for drug profiles, clinical trial, and pharmaceutical licensing agreements
  • Create trial and research and development profiles giving details of each clinical study / drug development program including key dates, status, phase, design, location, patient segment, endpoints, subject characteristics, treatments, and results etc
  • From different sources like clinicaltrials.gov, PubMed, medical journals, information from media releases, company website etc
  • Create and write pharmaceutical licensing agreements (upfront and milestone payments, shares involved in agreement transactions etc.) from various sources like media releases, SEC filings etc
  • Integrated new data sources into existing databases for more holistic view of product pipeline and organizational strategy
  • Conducted training sessions for junior researchers on process maps, statistical techniques to enhance their skill set.

Certification

Project Management Professional, 04/2024

Education

Post Graduate Diploma - Clinical Research & Management

Reliance Institute of Life Sciences, Mumbai
06.2009 - 07.2010

Final Grade: 63.40%

Bachelor of Pharmacy -

University of Mumbai, Mumbai
06.2005 - 06.2008
  • Final Grade: 70.00%

Diploma of Pharmacy -

Maharashtra State Board of Technical Education, Mumbai
06.2003 - 06.2005
  • Final Grade: 80.00%

Skills

Problem solving

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Accomplishments

  • Received highest employee inspire award (Thrive) twice in the year 2023 as well as in 2022 for handling projects very efficiently and exceeding the project objective within budget and saving (~$ 3 million) for the organization.
  • Received Gold Award for the remarkable performance in year 2021 for achieving the project SLAs consecutively six months.
  • Received “FRONTLINE LEADERSHIP” twice in 2019 and 2020 as a part of rewards and recognition to lead the team in successful submission of multiple adhoc periodic reports along with the managing regular reports meeting the SLA and compliance.
  • One of the selected candidates for “Global Pharmacovigilance project” by client within a period of year in 2010.
  • Received multiple monthly “Star of the Month” award for Best Productivity, Quality and Client impact.

Personal Information

  • Date of Birth: 05/15/1986
  • Nationality: Indian
  • Marital Status: Married
  • Visa Status: US B1/B2 Visa Holder

Disclaimer

I hereby declare the details furnished above are true to the best of my knowledge.

Timeline

Service Delivery Manager/Team Manager - Cognizant Technology Solution Pvt. Ltd.
02.2014 - 08.2021
Data Analyst/Team Lead (ICSR Quality Review Lead) - Cognizant Technology Solution Pvt. Ltd.
08.2011 - 01.2014
Jr. Data Analyst (Safety Processing Expert) - Cognizant Technology Solutions Ltd.
07.2010 - 07.2011
Reliance Institute of Life Sciences - Post Graduate Diploma, Clinical Research & Management
06.2009 - 07.2010
Research Analyst / Scientific Writer - WNS Global Services Ltd.
12.2008 - 07.2010
University of Mumbai - Bachelor of Pharmacy,
06.2005 - 06.2008
Maharashtra State Board of Technical Education - Diploma of Pharmacy,
06.2003 - 06.2005
Associate Director - Organon International
8 2021 - Current

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Deepak GuptaAssociate Director, RA/PV/QC Strategic Sourcing & Vendor Management