Riajul Islam

Help to Meet Quality & Compliance in Pharmacovigilance | Literature Monitoring | Audit | QMS | PVQA |RCA-CAPA| PBRER| MedDRA| SDEA |Team Lead| Training| Artificial Intelligence (AI Prompting)

Role
Drug Safety Scientist at Qinecsa Solutions
Location
Bengaluru, KA, IN
LinkedIn followers
500 followers

About Riajul Islam

The dose makes the poison. A small amount of a drug can be a medicine, but a large…

Experience

  1. Drug Safety Scientist

    Qinecsa Solutions

    Apr 2021 — Present · Mysore, IN

    Developed a comprehensive quality management plan to ensure compliance with regulatory guidelines, resulting in a 95% reduction in compliance issues. Implemented a new process workflow to minimize errors and enhance overall quality, reducing error rates by 80% and increasing productivity by 25%. Conducted training and quality meetings with clients, resulting in a 90% client satisfaction rate and a 40% reduction in client complaints. Proposed a new improvement plan, which led to a 30% increase in quality management process efficiency and a 20% reduction in costs. Prepared training and audit plans (internal & external), ensuring that 100% of employees were trained and equipped to follow quality processes, and the system was evaluated for effectiveness 4 times a year. Expand regulatory expertise on case collection and expedited reporting with regulatory agencies (e.g, FDA and EMA) Review individual reports to find missing information, determine if follow-up is needed to clarify the seriousness, expectedness, and cause of the event, and complete the case.• Responsible for team management and daily PV operations• Manage and implemented corrective and preventive actions (CAPAs) to address pharmacovigilance-related issues and prevent recurrence (e.g any deviation).

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Riajul Islam — Drug Safety Scientist at Qinecsa Solutions in Bengaluru, KA, IN | Unifers