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.
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.
Established a Pharmacovigilance (PV) Centre of Excellence that drove 15% business growth and expanded service portfolios to secure new client partnerships.
Launched a specialized consultancy to deliver tailored global pharmacovigilance solutions, sharpening my expertise to apply in a full-time leadership role.
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).
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).
Progressed to a senior leadership role, pioneering the Safety Signal Detection team and enhancing safety oversight for 12+ high-impact biologics.
Established and led a high-performing Aggregate Safety Reporting team for Johnson & Johnson Pharmaceuticals, directing recruitment, training, and operations.
Began my corporate career specializing in aggregate safety reporting for Bristol Myers Squibb, laying the foundation for my growth in global drug safety.
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.