Jatn Mali

Pharmacovigilance and Clinical Data Management professional with 4+ years of experience in ICSR case processing, adverse event reporting, signal detection, and oncology clinical trials. Proficient in Oracle Argus Safety, MedDRA, WHO Drug Dictionary, and Medidata Rave. Experienced in global regulatory compliance (FDA, EMA, ICH, GVP), narrative writing, and clinical data review from study conduct to database lock. Currently seeking international PV opportunities and open to relocation.

Senior Process Associate – Pharmacovigilance - Tata Consultancy Services (TCS) - Mumbai, India

(2026-04)

• Processing and managing ICSR cases in compliance with global pharmacovigilance regulations and client SOPs.
• Performing MedDRA and WHO-DD coding, narrative writing, and regulatory submission activities.
• Ensuring timely reporting of adverse events to regulatory authorities per ICH E2A/E2B guidelines.
• Supporting signal detection, safety data review, and compliance monitoring activities.

Assistant Professor – Pharmacology & Pharmacovigilance - Dr. L.H. Hiranandani College of Pharmacy - Mumbai, India

(2025-09 - 2026-04)

• Taught undergraduate and postgraduate courses in Pharmacology, Pharmacovigilance, and Drug Regulatory Affairs.
• Developed curriculum content on GVP guidelines, adverse event reporting, and drug safety regulations.
• Mentored pharmacy students on pharmacovigilance practices and regulatory compliance frameworks.
• Conducted practical sessions on MedDRA coding, ICSR processing workflow, and signal detection concepts.

Clinical Data Management & Pharmacovigilance Specialist - Cognizant Technology Solutions - Mumbai, India

(2021-03 - 2025-05)

• Processed 50+ serious and non-serious ICSR cases per week across spontaneous reports, NIS, MAPs, and patient support programs using Oracle Argus Safety.
• Performed end-to-end case processing: triage, data entry, medical review, MedDRA/WHO-DD coding, narrative writing, and case closure.
• Authored high-quality initial and follow-up narratives ensuring medical accuracy and compliance with GVP/ICH guidelines.
• Assessed case listedness against CCDS, SmPC, and product labeling with zero regulatory timeline breaches.
• Generated and resolved follow-up queries and discrepancies to obtain missing safety information within regulatory timelines.
• Coded AEs, indications, and drug history using MedDRA and WHO Drug Dictionary.
• Supported oncology clinical trials by reviewing clinical data and managing discrepancies in Medidata Rave.
• Performed external data reconciliation and supported database lock activities by completing lock checklists.
• Maintained audit and inspection readiness; supported internal quality reviews and compliance checks.

Master of Pharmacy - Pharmacy - University of Mumbai (2022)

Bachelor of Pharmacy - Pharmacy - University of Mumbai (2017)