Mohammad Irfan

About Mohammad Irfan

I am Mohammad Irfan, an accomplished Pharmacovigilance Specialist with 6+ years of experience in the pharmacovigilance domain. I specialize in ensuring drug safety, regulatory compliance, and have developed the ability to create effective presentations that align with organizational goals. Key Areas of Expertise:* Medical Literature Monitoring & Review: Expertise in literature screening and PubMed/EMBASE searches to identify safety signals and risks.* ICSR Case Processing: End-to-end experience in Individual Case Safety Reports (ICSRs) processing, adverse event reporting, MedDRA coding, narrative writing, and product coding via CDD and WHO Drug Dictionary.* Quality Review & Triage: In-depth knowledge of ICSR quality review, data entry, and triage, including COVID-19 vaccine cases.* Regulatory Compliance: Solid understanding of regulatory submission processes, ICH-GCP Guidelines, and GVP Modules to ensure global compliance.* Pharmacovigilance Database Expertise: Well-versed in using ARGUS and ARISg for effective case processing and data management.

Experience

1. Associate Pharmacovigilance Specialist

   Clarivate

   Jun 2024 — Present

   Medical Literature Monitoring: Conducted regular literature reviews using databases such as PubMed and EMBASE, identifying relevant articles to detect safety signals and adverse drug reactions.* Narrative Writing: Drafted clear, concise narratives for ICSRs, ensuring they met regulatory standards and accurately reflected patient experiences and outcomes.* Cross-Departmental Collaboration: Collaborated with medical, regulatory, and clinical teams to ensure timely submission of safety reports and to maintain compliance with global pharmacovigilance regulations.

Education

• IFTM University, Moradabad

  Bachelor of Pharmacy - BPharm

  2015 — 2019

• Jamia Hamdard

  Postgraduate Advanced Diploma in Drug Regulatory Affairs

  2023 — 2024