Indranath Bhattacharya

About Indranath Bhattacharya

Certified Project Management Professional (PMP) from PMI since 22-Apr-2023. Completed certification in Business management from Indian Institute of Technology-Delhi in Dec 2021. Of my 12+ years of experience in Pharmacovigilance (PV), I have been involved in core PV Project Management for 2 years and supported PV teams as an Operational Line Manager for over 3 years. Presently, as a Project Manager, I am managing multiple standalone safety studies (Post marketing and clinical trial studies) and some full-service studies acting as the Point of Contact for the clients, internal stakeholder(s) and study teams for the respective studies and maintaining a compliance of around 98%. As a part of my role, I’m involved in planning, resourcing, managing project finance and developing/ supporting various project plans like study specific Safety Management Plan (SMP), Medical Monitoring Plan (MMP) Project Management Plan (PMP), Project Risk Management Plan. I have managed multiple clinical and post marketing Pharmacovigilance studies and have hands on experience of working on different safety databases including Argus and Aris-g, managing multiple audits/ inspections, managing Quality Issues (QI) and developing Corrective and Preventive Actions (CAPA). I have prepared various study specific plans (Safety Management Plans) and initiated project set-ups for multiple clients. In my current role, I am managing 20-22 studies and 20-25 team members and as a Line Manager (LM), in my previous role, I used to manage a team of 20 members. As an LM, I was responsible to check my team billability, study assignment, training compliance, conduct regular meetings, schedule, and have Performance Development Conversations. I come with a vast experience in PV including over 4 years in core Case Processing, Case Reporting, Aggregate Report writing, Signal Detection, Risk Management Plan (RMP) preparation. I was one of the trained Argus Super Users from India and used to provide classroom training to new joiners. I have done master’s in clinical research and Pharmacovigilance from Birla Institute of Technology (BIT). I am a registered Pharmacist and trained pharmacovigilance professional.

Experience

1. Senior Project Lead

   Parexel

   Jul 2025 — Present · Hyderabad, IN

Education

• Birla Institute of Technology, Mesra

  Post graduate, Pharmaceutical Sciences

  2009 — 2011

• Dr. B. C. Roy College of Pharmacy and Allied Health Sciences 189

  Bachelor of Pharmacy, Pharmaceutical Technology

  2005 — 2009

• Indian Institute of Technology, Delhi

  Business management