Amit Kumar Das

Safety Associate Tainee @IQVIA.Pharmacovigilance Certified || Case narrative || ICSR processing || Vigibase || MedDRA coding || Oracle Argus || Data triage || Aggregate report || B. Pharmacy || D. Pharmacy ||

Role
Safety Associate Trainee at IQVIA India
Location
Kolkata, WB, IN
LinkedIn followers
500 followers
Healthcare & Human ServicesView LinkedIn profile

About Amit Kumar Das

Aspiring Drug Safety Professional with a Bachelor’s and Diploma in Pharmacy, backed by a certified pharmacovigilance course and hands-on experience in safety case processing. I specialize in adverse drug reaction (ADR) reporting, MedDRA coding, and the use of Oracle Argus for safety data management.Trained in global pharmacovigilance practices (GVP), ICH guidelines, and regulatory frameworks of EMA and FDA. I am well-versed in causality assessments (WHO-UMC, Naranjo’s Algorithm), signal detection, and aggregate report preparation (PSURs, DSURs). My internships in both hospital and industrial pharmacy settings have strengthened my clinical understanding and attention to detail.Passionate about contributing to patient safety and regulatory compliance, I am actively seeking opportunities in pharmacovigilance where I can support drug safety operations and grow within a collaborative, data-driven environment.Let’s connect if you\'re hiring or looking to collaborate in the field of drug safety and pharmacovigilance. B.pharmacy (20••••25) at SEACOM SKILLS UNIVERSITY.D. pharmacy (20••••21) at CONTAI POLYTECHNIC govt.

Experience

  1. Safety Associate Trainee

    IQVIA India

    Oct 2025 — Present · Kolkata, IN

    Learning and supporting end-to-end processing of Individual Case Safety Reports (ICSRs) • Assisting in collection, review, and data entry of adverse event information from various sources • Performing MedDRA coding for adverse events and WHODrug coding for medications under supervision • Supporting case quality checks to ensure accuracy, completeness, and regulatory compliance • Assisting with follow-up activities for missing or incomplete safety information • Gaining exposure to global pharmacovigilance regulations, SOPs, and safety databases • Maintaining confidentiality and compliance with pharmacovigilance guidelines

Education

  • Institute of Advanced Skill Development

    Pharmacovigilance certification course, Pharmacovigilance

  • Seacom Skills University

    Bachelor of Pharmacy - BPharm, Pharmacy

  • IASD (Institute of Advanced Skill Development)

    Pharmacovigilance course

  • Contai polytechnic

    Diploma in pharmacy, Pharmacy

  • West Bengal State Council of Technical & Vocational Education and Skill Development (WBSCT&VE&SD)

    D pharm, Pharmacy

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Amit Kumar Das — Safety Associate Trainee at IQVIA India in Kolkata, WB, IN | Unifers