Souvik Chatterjee

Background

About Souvik Chatterjee

Two decades experience in successful designing, implementation, quality assurance, compliance, digital enablement in Good Clinical Practices (GCP)/Good Pharmacovigilance Practices (GVP)/Computerized System Validation (CSV). • Hosted and participated in more than 15 regulatory inspections including US-FDA, MHRA, EMA, BfArM, Dutch Health authority and TGA inspections; Involved in more than 150 internal and external audits (pre-qualification, routine, sponsor, partner, Computer System Validation) • Proven track record in Delivery Management, Global Project Management, Client Engagement Management, Team building and Capability Development, Account Management, Complex RFI & RFP Management and Costing models • Certified PMI-PMP (waterfall and agile/Scrum project management), Agile practitioner, Lean and Six Sigma Black Belt professional offering over 19 years of experience in consulting in regulatory, quality and compliance in end-to-end drug development/marketing/regulatory submission, audit of. • Demonstrated skills in Collaboration, Conflict Resolution, Negotiation, Leadership, Change Management and Process Excellence, and leading large multi-cultural workforce Key Impact Areas • Pharmacovigilance, Good Clinical Practice and Safety Writing • Auditing/IT, Information security/data privacy audit/Health Authority inspection hosting • Business Transformation - Lean Six Sigma Black Belt (DMAIC & DFSS) • Capability development, Team Building & Leadership • Consulting, Account and Delivery Management Budget, P&L Management • Client Relationship Management • Project Management- Schedule, Cost and Resource management • SDLC & CSV (GAMP5, 21CFR Part 11) • Data analytics and artificial inteligence