Headline

Pharmacovigilance Associate / Analyst I ICSR Reviewer / Case Processor I Drug Safety Associate / Specialist I Medical Reviewer

About

🔬 I’m a certified Pharmacovigilance professional with 2+ years of experience in ICSR processing, MedDRA/WHO-UMC coding, narrative writing, and signal detection. At the Indian Pharmacopoeia Commission, I’ve contributed to national drug safety by processing 1000+ ADR cases using VigiFlow, training over 500 healthcare professionals, and maintaining 99% quality compliance in internal audits. 💊 With a Master’s in Pharmacy, I bring hands-on expertise in regulatory reporting (PvPI, WHO-UMC), literature screening, and safety database operations. I’m also skilled in using tools like Argus, Microsoft Office, and PubMed for documentation and screening. 🌐 Currently open to new opportunities in global drug safety teams, CROs, or pharma MNCs in roles such as Drug Safety Associate, Clinical Safety Analyst, or ICSR Reviewer — especially in Bangalore or hybrid setups. 📨 Let’s connect if you're hiring for PV talent or looking to strengthen your drug safety operations with audit-ready compliance and passionate execution.

Location

New Delhi

Work experience

Pharmacovigilance Associate at Indian Pharmacopoeia Commission, Mar 2023 - Present · 3 yrs 3 mos, On-site, Processed over 1,000 Individual Case Safety Reports (ICSRs) received from ADR Monitoring Centres and consumers using VigiFlow, a WHO-endorsed safety database. Conducted medical and quality review of safety reports, ensuring compliance with PvPI (Pharmacovigilance Programme of India) standards. Performed MedDRA coding of reported adverse events and drafted safety narratives based on clinical details. Managed case triage, seriousness assessment, completeness scoring, and upload to WHO-UMC database. Collaborated with MAHs (Marketing Authorization Holders), healthcare professionals, and AMCs to follow up on incomplete reports and resolve data discrepancies. Delivered pharmacovigilance process training to 500+ healthcare professionals, including medical students, nursing staff, and allied health workers. Supported signal detection and trend analysis by performing literature reviews using PubMed and reviewing case clusters. Key Tools & Systems Used: VigiFlow, MedDRA, Microsoft Excel/Word, PubMed, WHO-UMC dashboard Impact: Improved workflow efficiency by 25% through streamlining case intake. Maintained 99.3% accuracy in audit quality checks. Actively contributed to National Pharmacovigilance Week 2024 by evaluating posters and educating stakeholders.

Project Trainee at National centre for cell science, Feb 2022 - Aug 2022 · 7 mos, Pune District, Maharashtra, India, Responsibilities: Conducted molecular biology and protein purification experiments as part of M. Pharm dissertation. Worked on gene cloning, expression systems, and chromatography techniques under a central government research institution. Gained exposure to wet lab documentation, research protocol adherence, and technical reporting — indirectly contributing to scientific thinking and data quality, a core skill in PV case analysis

Hospital Pharmacist at Prakash Hospital Noida, Jun 2019 - Jul 2019 · 2 mos, Noida, Uttar Pradesh, India

Internship Trainee at Datt Mediproducts Pvt. Ltd., Jan 2019 - Feb 2019 · 2 mos, East delhi, Project Title: “Post-Marketing Surveillance (PMS) of a Medical Device with Special Reference to EU MDR & Clinical Trial Registration (India)” Responsibilities: Reviewed EU MDR regulations applicable to Class II/III medical devices. Conducted a gap analysis of existing PMS practices vs EU MDR standards. Contributed to writing PSUR, PMS Plan, and Summary of Safety and Clinical Performance (SSCP). Supported risk-benefit analysis, EUDAMED data entry, and ClinicalTrials.gov registration. Learned the importance of post-market evidence collection, applicable to PV work in real-world safety analysis.

Apprentice pharmacist at Promhex Multi-specialty Hospital, Jun 2018 - Jul 2018 · 2 mos, Greater noida

Education

M.pharm, Biotechnology, Delhi Pharmaceutical Sciences and Research University (DPSRU)

Bachelor's degree, Pharmacy, RAM-EESH INSTITUTE OF VOCATIONAL & TECHNICAL EDUCATION