Professional Experience

AI & Automation Pioneer

Co-engineered critical pharmacovigilance tools, including SigTRACE for signal management and LITRACE, an automated Artificial Intelligence (AI) literature search tool. By implementing these solutions, expert manpower was refocused on high-value tasks, enhancing efficiency and reducing operational costs.

Safety Governance Leader

Served as European Union (EU) Qualified Person for Pharmacovigilance (QPPV) back-up & local QPPV as required; represented Novartis at Data Safety Monitoring Boards, Medical Safety Review Boards, Product Stewardship Board, & various Global Health Authority interactions on safety; and secured regulatory approvals for Sputnik V vaccine production.

Business Growth Driver

Established a Pharmacovigilance (PV) Centre of Excellence that drove 15% business growth and expanded service portfolios to secure new client partnerships.

Career Timeline

Founder & Freelance Pharmaceutical medicine & Pharmacovigilance Consultant

Phoenix Neumed – A RR Group | Apr 2022 - Present

Launched a specialized consultancy to deliver tailored global pharmacovigilance solutions, sharpening my expertise to apply in a full-time leadership role.

  • Developed bespoke PV systems, improving client compliance and efficiency.
  • Trained 90+ industry professionals in advanced medical safety assessment.

Associate Director heading PV & Chief Biosafety Officer

A Strides Enterprise (Arcolab & Stelis Biopharma) | Nov 2020 - Mar 2022

In a unique dual capacity across two Strides Enterprise companies, directed the Global Pharmacovigilance function within the Medical Affairs division at Arcolab, while concurrently entrusted with establishing and leading biosafety governance at Stelis Biopharma for the critical Sputnik V vaccine program during the COVID-19 pandemic (2020–2021).

  • At Arcolab: Spearheaded U.S. Food and Drug Administration (FDA)-mandated safety analysis for ranitidine, ensuring regulatory compliance.
  • At Stelis: Was pivotal in securing Review Committee on Genetic Manipulation (RCGM) approval for Sputnik V vaccine production under strict aseptic conition with safety precautions & surveillance for Russia.
  • Across Enterprise: Pioneered automation-driven framework enhancements in global pharmacovigilance, delivering measurable efficiency gains, cutting processing times by 15%, and transforming regulatory responsiveness.

Associate Director – Medical Sciences

Bioclinica India Pvt. Ltd (now Qinecsa) | May 2017 - Apr 2020

Provided strategic leadership to the Centre of Excellence, directing the medical function and leading 5 major projects with a team of ~110 Full-Time Equivalents (FTEs).

  • Drove 15% business growth by expanding the PV service portfolio.
  • Delivered EU QPPV services and oversaw comprehensive regulatory compliance.

Senior Pharmacovigilance Leader

Novartis Health Care Private Limited | Oct 2009 - Oct 2016

Progressed to a senior leadership role, pioneering the Safety Signal Detection team and enhancing safety oversight for 12+ high-impact biologics.

  • Received multiple "Above & Beyond" and "Novartis Development" awards.
  • Maintained exceptional compliance, leading teams through numerous internal audits with minimal findings and over 15 major inspections (no critical/major findings) from global health authorities. These included the FDA, European Medicines Agency (EMA) and its Pharmacovigilance Risk Assessment Committee (PRAC), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Australia’s Therapeutic Goods Administration (TGA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), while also supporting local inspections for Country Pharma Organizations (CPOs) worldwide.
  • Served as faculty for Novartis's Advanced Program in Pharmaceutical Medicine.

Associate Manager – Aggregate Reporting

Quintiles Transnational (now IQVIA) | Aug 2008 - Sep 2009

Established and led a high-performing Aggregate Safety Reporting team for Johnson & Johnson Pharmaceuticals, directing recruitment, training, and operations.

  • Recognized with 'Manager of the Quarter' and 'Distinguished Performance' awards.
  • Served as a Subject Matter Expert (SME) for the Johnson & Johnson Benefit Risk Management portfolio.

Assistant Operations Manager, Global Pharmacovigilance & Epidemiology

Accenture (Client: Bristol Myers Squibb) | Apr 2007 - Aug 2008

Began my corporate career specializing in aggregate safety reporting for Bristol Myers Squibb, laying the foundation for my growth in global drug safety.

  • Recognized as an SME for leadership in Aggregate Safety Reporting.
  • Honored with two "Quarterly Super Star" awards for exceptional performance.

Foundation in Clinical Practice

Medical Officer, ICU In-Charge & Clinical Investigator

This hands-on experience as a Junior Resident, Intensive Care Unit (ICU) In-Charge, and Clinical Co-investigator in various critical areas like cardiology, nephrology and pulmonology including site management & contract research organization services in medical & radiation oncology, psychiatry and neurology informs my deep commitment to patient safety in every aspect of drug development.