S

Souvik Bit

CEO

Bengaluru, Karnataka, India18 yrs 2 mos experience
Most Likely To SwitchHighly Stable

Key Highlights

  • Led multi-million dollar AI-driven safety system projects.
  • Expert in digital transformation and regulatory compliance.
  • Passionate about holistic wellness and leadership development.
Stackforce AI infers this person is a Healthcare and SaaS expert with strong leadership in AI-driven solutions.

Contact

Skills

Core Skills

Artificial Intelligence (ai)PharmacovigilanceHolistic Wellness CoachingData ManagementProduct DevelopmentLeadershipProject Management

Other Skills

Agile CoachAgile MethodologiesBudgetingBusiness AnalysisBusiness DevelopmentBusiness Process MappingBusiness RequirementsCRMChange ManagementClinical Trial ModernizationCloud ComputingContract NegotiationCross-functional Team LeadershipData AnalysisData Cleaning

About

With over four years at ArisGlobal as Senior Director, I lead service delivery for safety systems; managing large-scale SaaS safety implementations and on-premise to cloud transformations. Our applications leverage the latest AI technology within highly regulated environments. Focusing on operational goals including EBITDA, quality, CSAT, and delivery excellence, I contribute to multi-million-dollar projects by fostering high-performance teams and developing robust governance processes aligned with organizational objectives. I am deeply committed to fostering a “culture-of-growth,” empowering young talent, and nurturing ecosystems that encourage continuous professional development. Leveraging expertise in emerging technology trends, AI, and data solutions, I support ArisGlobal’s mission to drive impactful digital transformation and exceed the expectations of stakeholders and clients. Beyond my corporate leadership, I am passionate about holistic health and wellness, serving as a fitness coach/buddy dedicated to helping busy professionals and executives unlock their peak potential. I believe that true leadership extends beyond the boardroom, rooted in physical vitality, mental clarity, and emotional resilience. Through personalized, evidence-based fitness and small lifestyle changes, I empower people unlock sustainable habits that boost energy, reduce stress, enhance focus, and elevate overall productivity. This dual focus: on transformative leadership at work and transformative wellness in life; creates a synergistic approach to personal and professional excellence. Looking forward to with like-minded leaders who value high performance, balanced living, and continuous growth.

Experience

Arisglobal

Senior Director

Sep 2021Present · 4 yrs 6 mos · Bengaluru, Karnataka, India · Hybrid

  • Lead service delivery for AI-driven pharmacovigilance systems, spearheading Agentic AI integration into SaaS/cloud platforms to optimize adverse event detection, signal management, and safety data automation.
  • Oversaw multi-million dollar SaaS implementations leveraging machine learning, NLP, and autonomous AI agents to accelerate drug safety workflows, ensuring global regulatory (FDA, EMA, GxP) compliance.
  • Drove strategic digital transformation by designing AI-powered risk management, predictive analytics, and real-time safety surveillance for client outcomes.
  • Built and mentored cross-functional teams for AI model validation, pharmacovigilance automation, and data governance, fostering innovation and compliance.
  • Established scalable governance and QA for Industry 4.0: automated compliance pipelines, pharmacovigilance signal detection, and AI explainability standards.
  • Collaborated with global biopharma clients, regulatory agencies, and consulting partners to deliver AI-powered safety solutions reducing cycle times and optimizing resource allocation.
  • Championed Agentic AI orchestration, federated learning, and generative AI for clinical safety metadata enrichment and automation.
  • Reported key KPIs: EBITDA growth, delivery excellence, CSAT, and compliance metrics, consistently aligning with board-level objectives.
BudgetingPharmacovigilanceProduct DevelopmentTeam LeadershipData ScienceGlobal Delivery+13

Iqvia

4 roles

Director

Promoted

Jul 2019Sep 2021 · 2 yrs 2 mos

  • Led digital transformation for global clinical development and data management, pioneering adoption of Agentic AI in trial design, data orchestration, patient safety, and real-world data integration.
  • Oversaw implementation of AI-powered agents for autonomous data reconciliation, anomaly detection, and automated issue triage, enabling proactive risk-based monitoring across multicountry trials.
  • Drove clinical trial modernization by integrating tools for predictive analytics, protocol optimization, and real-time patient recruitment using agentic architectures, massively reducing site activation timelines and improving subject diversity.
  • Partnered with pharma sponsors and CROs to deploy explainable AI for clinical event adjudication, eSource validation, and ICH-M11 digital data flow—delivering faster database locks, higher data quality, and 30% lower SDV backlog.
  • Introduced federated learning protocols for privacy-preserving cohort analyses and advanced AI-driven literature review agents to support rapid evidence synthesis and innovation in trial methodology.
  • Championed end-to-end regulatory compliance and data governance for AI/ML deployments, collaborating on NIM (NeMo Infrastructure Management) agent solutions to accelerate data curation, outlier triage, and cross-system automation in support of new therapy submissions.
  • Delivered measurable ROI: 37% reduction in query resolution times, 13 days faster database lock, and new frameworks for continuous improvement in clinical trial operations.
BudgetingProduct DevelopmentTeam LeadershipData ScienceGlobal DeliveryPMO set-up+7

Associate Director

Promoted

Jan 2018Jun 2019 · 1 yr 5 mos

  • Delivery Lead for multi-million dollar account deliveries from India with an approx. 100 member team for the registry practice EDC program
  • KPIs for delivery lead include career planning and annual reviews, compensation planning, EBITDA targets and gains, Strategic discussions and key leadership governance discussions
  • Represent India Senior leadership for the Registry program
  • Key stakeholder within the leadership team for communications and escalation management
Product DevelopmentTeam LeadershipData CleaningGood Clinical Practice (GCP)Data ManagementService Delivery Management+2

Senior Project Manager

Jan 2016Dec 2017 · 1 yr 11 mos

  • Proven track record in heading various systems according to business needs (as-is & to-be analysis) and reviewing process flow as per the specifications.Expertise in directing cross-functional teams by using interactive and motivational leadership skills with an equal desire to win.Leveraged skills in performing functions entailing Clinical Data Management / Vendor / Contract Management, Custom product configuration deliveries, COTS Electronic Data Capture (EDC) Product Integration.Comprehensive knowledge of EDC products like Inform, Rave & Infosario Outcome, Clinical Trial Data Management for Phase I,II,III & Phase IV Clinical Research Trial, Electronic Patient Reported Outcomes, Pharmacokinetic and Pharmacodynamic clinical trial configurations, EDC driven Pharmacovigilance, 21 CFR Part 11 & GxP Standard based electronic data management
  • Accountability for the compete technical project management function for EDC program Delivery Center in Bangalore
  • Lead a team of 15 Project Managers including their career planning and appraisals
  • Accountable for Managing Leadership communications in terms of Monthly Reviews of the project management function
  • Administering Real world late phase observational study in terms of EDC product implementation for key pharma and healthcare customers
  • Represented ‘EDC Product SME’ across the complete function and participating in RFPs
Data CleaningGood Clinical Practice (GCP)Data ManagementProject ManagementService Delivery Management

Project Manager, India IT

Sep 2014Dec 2015 · 1 yr 3 mos

  • Acted as one of the Key Project manager across complete real world late phase observational studies and EDC implementation for several sponsor projects using Agile scrum delivery framework
  • Worked as ‘Product Manager’ and coordinated EDC implementations across various customers
  • Supervised a cross-functional project teams from Business Development, System Analyst, Data Manager, Developer, Software Quality Analyst, Technical Support and Production Service Manager
  • Administered functions related to identification of resources for each configuration releases, development of documentation template for project planning, execution of best practices with project management functions, technical requirements gathering process for EDC systems
Data CleaningData ManagementProject ManagementService Delivery Management

Self-employed

Fitness Coach & Wellness Advisor (Part-Time / Self-Employed

Mar 2019Present · 7 yrs · Remote

  • Helping busy professionals and executives elevate their physical and mental performance to achieve sustainable success.
  • Design and deliver personalized fitness programs tailored for high-performance individuals balancing demanding careers.
  • Coach on holistic wellness strategies incorporating physical fitness, stress management, nutrition, and mindset for long-term productivity and resilience.
  • Empower clients to build sustainable habits that improve energy, focus, work-life balance, and leadership presence.
  • Leverage evidence-based practices and continuous learning to stay updated on health trends and fitness innovations.
  • Build a supportive community of professionals committed to enhancing their well-being alongside career growth.
MindsetHolistic Wellness Coaching

Hcl technologies

2 roles

Associate Business Manager

Promoted

Jan 2012Sep 2014 · 2 yrs 8 mos

  • Presently working on a large application Decommissioning project for one of the Pharmaceutical Majors in Europe.Responsible for End to End project management and I am involved in project estimations, service delivery planning and scheduling, resource management and Contract Scope management.I am responsible for managing resources from both HCL and Vendor Companies from Onsite and Offshore locations.I am involved in negotiations of contracts and closing deals
  • Single point for contact for project service delivery, Vendor and contract Management, Demand and relationship Management and coordinating the invoicing and BR processes.
PMO set-upGood Clinical Practice (GCP)Project Management

Senior Business Analyst

Jun 2010Oct 2012 · 2 yrs 4 mos

  • Was working as a Project Lead for various projects in Clinical Trial Space for one of the large pharmaceutical major in the world. I was responsible for ensuring smooth services delivery in Preclinical, Clinical, safety and regulatory business areas within the Client organization. I worked closely with client stakeholders in understanding their requirements and aligning project teams to deliver services to meet customer satisfaction. Was responsible for coordination of onsite and Offshore Teams and aligning the resources of the project team to provide 24*7 support model for the Client Business Processes. I was responsible to work with project teams that involved delivering of production support to Client processes to make sure that all appropriate SLA levels are being achieved. I was responsible for coordinating the Incident, Problem and Change management processes. I was responsible for proper escalation management and performing Root cause analysis for any service Disruptions. I was responsible for collaborating with project Teams to make sure that the Business and technical requirements/solutions are well aligned with customer expectations. Was responsible to ensure that the quality of deliverables were as per the expected Client standards and overall project met HCL Goal Metrics
Good Clinical Practice (GCP)

Organization - hcl technologies

Business Analyst

Jan 2009Dec 2009 · 11 mos · Noida Area, India

  • Worked onsite(US) as a Business Analyst for Phase I and Phase II Clinical trial studies for one of the largest Pharmaceutical companies in the world. Was involved in Study structuring, identification of protocol challenges, collector development for phase I clinical trials on European and North American sites. Was involved in understanding of clinical trials business requirements, identification of various technological advancements related to applications and tools in Clinical trial space, Clinical Trials related data management and various levels of data analysis and troubleshooting within legacy group of trial management applications. I was a liaison among project stakeholders for eliciting, analyzing, communicating and validating requirements for changes to business processes involving technology. I was responsible for translating Business requirements from Clinical trial study protocols to functional specifications for configuring metadata and deploying collectors for capturing Clinical trial data. I was responsible for providing End user support and troubleshoot production systems using my strong technical and problem solving skills. I was responsible for coordination of the onsite and offshore teams for delivering services to client in a timely manner. Had executed roles of Defect Prevention Analyst(DPA) and Project Quality Assurance(PQA) for these projects
Good Clinical Practice (GCP)

Reliance lifesciences ltd and hcl technologies ltd

2 roles

Management Trainee

May 2007Dec 2008 · 1 yr 7 mos · Chennai Area, India

  • Worked as a key stakeholder for the PMO for Customer at HCL, Location. Briefed directly to
  • Business Unit head of Customer at HCL. Was handling the billing and invoicing of the integrated Customer account at HCL. Directly reported to both Delivery and Sales head of Merck account at HCL and was engaged in preparation of major Senior Management Review presentations, Metrics Monitoring, Resource Movements, Tracking of new business opportunities, Cross functional interactions between various stakeholders within the management organization, Client level status report presentations, Requirement gathering for any RFPs, skill wise capability building, Knowledge and Document management and Quality management. I was involved in making Engagement Case studies, White papers and collaterals. At Client Relationship level, PMO was single point of contact for contract management, financial management, metrics management and customer relationship management and being a major stakeholder of PMO, I had played a major role in these areas as well. I had executed a Six Sigma project for optimization of the billing process which was routed through the PMO and the was awarded the Six Sigma Green Belt certification for the process improvement and Dollar savings

Management Trainee

Sep 2006Jan 2007 · 4 mos

  • Reliance Lifesciences Pvt Ltd: As a Management trainee I was involved in prelaunch Market Analysis and Survey for a New Product Launch. I was involved in analyzing different phases of Product Lifecycle (PLC).Survey methodology adopted was questionnaires and personal interview with the end users(doctors) of the high end hospitals gathering requirements on the different aspects of the new product.

Education

Amity University

Master of Business Administration - MBA — International Marketing

Apr 2005May 2007

Amity University

MBA

Jan 2005Jan 2007

Meerut University

B.Sc(H) — Biotechnology

Jan 2002Jan 2005

Denobili School,FRI

10+2 — Science

Jan 1992Jan 2002

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