Datta Kadam

About Datta Kadam

A dynamic pharmacovigilance leader with over 19 years of rich experience leading all facets of PV operations in the healthcare sector with all regional clients US/EU/JP. Strategic thinker with proven capacity to implement effective Pharmacovigilance strategies in adherence with industry best practices, trends, and legislation requirements to meet shared goals. Leading a team of 100+ team members (all level) and demonstrated management skills with People Management, Operation Excellence, Project Management, Process Optimization, Excellent client communication, Business Development (RFP/RFI/ Bid Defence), Budgeting, Resourcing, Transition Management, Recruitment, and Training.Professional Experience (Drug Safety):ICSR Case Processing (Drug & Vaccine), Medical Device Reporting (MDR), Risk Management Plan (RMP, ACO), Aggregate Reporting - PSURs, DHPC, PV Agreements, Pharmacovigilance System Master File (PSMF), Assisted to EU-QPPV/Deputy QPPV for PV activities, Annual basis Risk-Based Inspection report (MHRA), Audit & Inspection Management.

Experience

1. General Manager - Pharmacovigilance

   Elite Safety Sciences

   Apr 2024 — Present

Education

• Amravati University

  B-Pharm, Pharmacology,pharmaceutics,pharmachemishtry,pharmacognosy

  2001 — 2005

• Microsoft Education Partner

  Power BI Data Intelligence

• Exemplar Global

  ISO 9001:2015 Certified QMS Lead Auditor , ISO 9001 Certification

• SYMBIOSIS INTERNATIONAL UNIVERSITY

  CCRC, Clinical Research

  2008 — 2008

Skills

• Clinical Trials
• Ich-Gcp
• Pharmaceutical Industry
• Sop
• Fda
• Drug Safety
• Pharmacovigilance
• Pharmaceuticals
• Quality Assurance
• CRO
• Pharmaceutics
• U.s. Title 21 Cfr Part 11 Regulation
• Clinical Monitoring
• Gcp
• Regulatory Submissions
• Clinical Development
• Life Sciences
• Clinical Trial Management
• CRO Management
• 21 Cfr Part 11
• Quality Management
• Clinical Research
• Standard Operating Procedure (Sop)
• Meddra
• Good Clinical Practice (Gcp)
• Lifesciences
• Ctms