Professional Experience
Founder & Freelance Consultant – Phoenix Neumed (RR Group)
Apr 2022 – Present
- Developed tailored Pharmacovigilance (PV) systems for small/medium clients, improving compliance by 40%.
- Delivered training on medical safety assessment to 90+ industry professionals.
Associate Director – Pharmacovigilance & Medical Affairs, Arcolab Pvt Ltd
Nov 2020 – Mar 2022
- Led global PV functions: signal management, aggregate reporting (PSURs, PBRERs), and audits/inspections.
- Implemented RMP and PSMF automation, reducing process time by 15%.
Global & Chief Biosafety Officer – Stelis Biopharma Pvt Ltd
Nov 2020 – Mar 2022
- Built Sputnik V vaccine safety system, secured RCGM/IBSC approvals, and oversaw biosafety compliance for BSL-3/4.
- Developed and maintained global biosafety SOPs and emergency protocols.
Associate Director – Medical Sciences (CoE), Bioclinica India (Qinecsa)
May 2017 – Apr 2020
- Established India PV Centre of Excellence; drove 15% business growth in PV services.
- Created “LITRACE” AI tool for automated literature mining, reducing review time by 40%.
Clinical Scientific Expert II – Cardio‑Metabolic TA, Novartis
Oct 2015 – Oct 2016
- Led DSURs and PBRERs for Cardio‑Metabolic pipeline; supported interim safety analyses and investigator safety boards.
- Mentored junior clinical safety physicians and streamlined adverse event reconciliation across databases.
Pharmacovigilance Expert → Senior PV Leader – Immunology & Dermatology TA, Novartis
Oct 2009 – Oct 2015
- Served as EU QPPV backup; led global aggregate reporting for 12+ biologics and specialty portfolios.
- Received 2× “Above & Beyond” awards and part of the team that earned the “Novartis Development Award.”
Associate Manager – Aggregate Reporting Scientist, Quintiles (IQVIA)
Aug 2008 – Sep 2009
- Delivered high‑quality PSURs, PADERs, and Summary Bridging Reports across oncology, cardiovascular, neurology.
- Mentored safety reporting scientists and led the operational management for J&J portfolios.
Assistant Operations Manager – Accenture
Apr 2007 – Aug 2008
- Oversaw medical safety review processes for Bristol Myers Squibb, managed team of safety physicians.
- Recognized as Subject Matter Expert and won 2× “Quarterly Superstar” awards.
Clinical Research Co‑ordinator & Medical Officer – Various Hospitals
Feb 2004 – Apr 2007
- Co‑ordinated cardiology and ICU patient care at PSG, Ellen, H.S. Hospitals; served as Clinical Investigator in cardiology trials.
- Managed clinical data collection and quality control for multiple research studies at Malabar Medical Centre and Ellen Hospitals.
Junior Resident & ICU In‑Charge – PSG Hospitals, Coimbatore
Oct 2004 – Mar 2005
- Provided direct patient care in ICU, managed critical cases, and assisted in clinical drug trials.
- Co‑investigator for cardiology studies; supported protocol design and patient enrollment.
Key Achievements
- Phoenix Neumed: Improved client compliance by 40% through tailored PV systems and training delivery.
- Arcolab: Spearheaded FDA‑mandated Ranitidine safety review and streamlined PV automation by 15%.
- Stelis Biopharma: Secured RCGM/IBSC approval for Sputnik V vaccine production; established biosafety protocols.
- Bioclinica: Invented “LITRACE” AI literature tool, reducing manual review time by 40%, and drove 15% business growth.
- Novartis (Cardio‑Metabolic): Led interim safety analyses for acute heart failure trials; authored DSURs and CSRs.
- Novartis (Immunology & Dermatology): Received 2× “Above & Beyond” awards; served as EU QPPV backup.
- Quintiles: Built high‑performing aggregate reporting team for Johnson & Johnson; recognized with Distinguished Performance award.
- Accenture: Nominated SME for PV operations; earned 2× Quarterly Superstar awards.
- Clinical Practice (2003–2007): Coordinated cardiology and ICU clinical research, managed patient care, and supported trial protocol design.