Vishnu Garje

About Vishnu Garje

Pharma graduate PV Manager and has over 10 years of experience in field of pharmacovigilance, PMS, Clinical Trials and Vaccine project setup and management experience.Working as Group Leader, dealing with project initiation, planning, conduct and transition at the customer account level.Managing multiple customer and contributing business units for one or more large projects covering single or multiple functions may be clinical trial or post-marketing studies.Monitoring the use of consistent tools and methodologies, identify and evaluate potential project risks and develop mitigation plans.Hands on preparing Initial work order, Master service agreement, General service agreements, resourcing, scope finalisation, financial aspects of project and Invoicing.Setup of Safety Databases (Veeva, Argus & Argus J), internal safety tracking systems for compliance and quality monitoring.Vendor Management and Management of ICSR Team based in Europe and India.Hands-on experience of Individual case safety reporting (ICSR, SAE, AE) for vaccines and pharmaceutical drugs and Advent.Handled team of about 500 FTEs in pharmacovigilance operations across multiple locations and have excellent team management qualities, tracking high team performance and appropriate appreciation, retention policies.Collaborate with other operations managers to address problem areas, work scheduling for current and projected projects, staffing needs, equipment needs, and projected peak workloads, ensuring global consistency and report utilization of staff.

Experience

1. Manager

   Tata Consultancy Services

   Aug 2023 — Present · Thane, IN

   Leadership and Team Management Communication and Stakeholders Management Pharmacovigilance Strategy Development Risk Management Regulatory Compliance Collaboration with Cross-functional teams QMS Auditor Subject Matter Expert (Pharmacovigilance domain, Argus Safety, Veeva Vault Safety) Vendor Management and Governance Audits and Inspections Training and Delivery Database and Product Transitions Transition Management

Education

• Savitribai Phule Pune University

  Bachelor of Pharmacy (B.Pharm.)

  2009 — 2013

Skills

• Microsoft Excel
• CRO
• Medical Records
• Meddra
• Icd-9-Cm
• Special Projects
• Pharmacovigilance
• Patient Safety
• Radiology
• Good Clinical Practice (Gcp)
• Cpt
• Clinical Trials
• Sop
• Drug Safety
• Medical Terminology
• Medical Coding
• Gcp
• Presentation Skills
• Healthcare
• Hospitals
• 21 Cfr Part 11
• Ich-Gcp
• Regulatory Affairs
• Clinical Data Management
• Medical Writing
• Clinical Research