Siva Kumar Buddha

About Siva Kumar Buddha

"First, do no harm"—the Hippocratic Oath sparked my journey in medicine, but my mission to create impact led me beyond hospital walls into the global ecosystem of pharmacovigilance. With wide experience across product safety, signal & risk management, and PV operations, I’ve evolved into a passionate builder of next-generation pharmacovigilance systems—powered by technology, led by purpose. Today, I can handle large-scale safety programs that integrate AI, LLMs, and automation to enhance quality, compliance, and scalability. My work includes spearheading PV transformations, managing cross-functional global teams, and driving outcomes that save lives, reduce costs, and scale operations. From designing signal detection frameworks to implementing end-to-end case processing solutions, I partner with global pharma and biotech companies to align safety strategy with execution. I bring a strong mix of team leadership, budget ownership, program governance, and stakeholder alignment—all grounded in scientific integrity. Select Highlights: • Led multi-million-dollar pharmacovigilance projects from RFP to delivery—partnering with clients to co-build future-ready safety ecosystems. • Built and scaled Gen AI-powered PV automation tools, now embedded in the operations of top pharma brands. • Trained 700+ safety professionals and SMEs across geographies—upskilling teams in AI/LLM-based case processing and safety intelligence. • Designed Agentic + LLM-integrated workflows for ICSRs, signal detection, and aggregate reports—balancing innovation with compliance. • Delivered high-impact conference talks across global PV platforms—advocating for smarter safety systems and real-world problem-solving. What drives me? A relentless curiosity, deep respect for patient safety, and the belief that tech + teamwork can redefine what's possible in pharmacovigilance. Specialties: Signal & Risk Management | Safety Automation & AI | PV Training & Leadership | End-to-End Case Processing | Global Program Management | RFP/RFI Solutioning | SME in LLMs for PV | Stakeholder & Budget Management | Conference Speaker & Thought Leader

Experience

1. Medical Director Global Patient Safety

   Amgen

   Jul 2025 — Present

2. Director Pharmacovigilance, Head of Signal and Risk Management / Safety Gen AI Solutions

   Indegene

   Nov 2023 — Jul 2025

3. Global Phv Surveillance Physician Sr Manager, Medical Scientific Unit.

   Teva Pharmaceuticals

   Feb 2022 — Nov 2023

4. Global Safety Physician Manager : Product Safety & Risk Management

   Viatris

   Sep 2020 — Feb 2022

5. SME/ Safety manager/ Safety Physician

   Indegene

   Aug 2016 — Sep 2020

6. Safety Physician

   Sciformix

   Apr 2015 — Jul 2016

7. Drug Safety Physician/Medical Reviewer

   Synowledge LLC

   Nov 2013 — Apr 2015

8. CMO

   Vikram Hospital (Bengaluru) Pvt Ltd.,

   May 2013 — Apr 2015

9. Emergency Physician

   Aditya Birla Memorial Hospital

   Sep 2008 — Apr 2013

Education

• SVKM's Narsee Monjee Institute of Management Studies (NMIMS)

  Master of Business Administration - MBA (Wx) · Leadership and Strategy & Operations and Supply Chain

• Government Medical College

  Bachelor of Medicine · Bachelor of Surgery (MBBS), MEDICINE

Skills

• Medical Coding
• Signal Management
• Leadership
• Cross-Functional Team Leadership
• Drug Safety
• Medical Writing
• Pharmacovigilance
• Clinical Trials
• Meddra
• Clinical Research
• Clinical Pharmacology
• Medicine
• Medical Terminology
• Arisg
• Psurs
• Gcp
• Pharmacology
• Therapeutic Areas
• Healthcare
• Ich-Gcp
• Pharmaceutical Industry
• Medical Education
• Regulatory Affairs
• Medical Review
• Registered Duty Doctor
• Ich Guidelines
• Hospitals
• Adverse Event Reporting
• Clinical Operations
• Lifesciences
• Neurology
• Life Sciences
• Clinical Development
• Good Clinical Practice (Gcp)
• Tara Pv