{
  "$schema": "https://cvjson.com/schema/v1.json",
  "basics": {
    "name": "ZUMERA FATIMA",
    "label": " Pharmacovigilance & Regulatory Affairs Professional   | AI-Enabled Process Automation",
    "summary": "Pharmaceutical professional transitioning toward AI-driven automation, with hands-on experience in pharmacovigilance and regulatory affairs. Experienced in developing practical automation solutions to streamline pharmaceutical workflows, enhance efficiency, and support regulatory and safety-related processes.",
    "location": "Qatar"
  },
  "work": [
    {
      "company": "",
      "position": "REGULATORY AFFAIRS EXPERIENCE",
      "startDate": "2025-09",
      "endDate": "2026-01",
      "highlights": [
        "Supporting CTD authoring and dossier preparation on smart e-CTD.",
        "Familiarity with eCTD concepts, document lifecycle, PDF bookmarks, hyperlinks and table-of-contents requirements.",
        "Exposure to regulatory intelligence, change-control assessment and regulatory impact evaluation.",
        "Developing AI-based solutions to support regulatory document review and regulatory intelligence activities."
      ]
    },
    {
      "company": "Yashfin Consulting Services",
      "position": "PHARMACOVIGILANCE EXPERIENCE",
      "startDate": "2023-02",
      "endDate": "2025-08",
      "highlights": [
        "One year of experience in Pharmacovigilance, with experience across ICSR processing and safety case workflows.",
        "Experience with case intake, data review, assessment, follow-up and documentation activities.",
        "Working knowledge of seriousness, causality, MedDRA coding and ICSR quality requirements. Exposure to ICSR narrative preparation and pharmacovigilance documentation.",
        "Working knowledge of PSUR/PBRER and RMP concepts, with limited practical preparation experience.",
        "Familiarity with QPPV/LQPPV, PSSF and PSMF concepts and regional pharmacovigilance requirements.",
        "Interested in applying AI and automation to improve repetitive PV processes while maintaining appropriate human review."
      ]
    },
    {
      "company": "",
      "position": "AI & AUTOMATION EXPERIENCE",
      "highlights": [
        "Applied Generative AI, Large Language Models (LLMs), RAG and workflow automation to develop practical solutions for Pharmacovigilance and Regulatory Affairs use cases.",
        "Developed an AI-powered Regulatory Intelligence/RMP tool using a RAG-based approach to retrieve relevant information from uploaded regulatory documents and provide document-grounded responses.",
        "Developed an AI-assisted Regulatory Change Control evaluation workflow to assess proposed changes, identify potential regulatory impact, determine relevant regulatory actions and map applicable CTD/module considerations.",
        "Developed an AI-assisted ICSR narrative generation workflow to structure case information and support the drafting of safety narratives, reducing repetitive manual effort.",
        "Developed a PV/ICSR triage workflow to support preliminary case assessment and routing based on defined criteria.",
        "Explored a voice-to-ICSR workflow that converts voice input into structured safety information for further processing.",
        "Built practical workflow automations using tools including n8n, Flowise and LangChain, with exposure to Python, SQL and AI APIs.",
        "Focused on developing human-in-the-loop solutions, where AI supports information retrieval, drafting, classification and workflow efficiency while final professional and regulatory decisions remain subject to human review."
      ]
    }
  ],
  "education": [
    {
      "institution": "Dr. Babasaheb Ambedkar Marathwada University (BAMU), Aurangabad, India",
      "degree": "Master of Pharmacy",
      "field": "Pharmacy",
      "endDate": "2013"
    },
    {
      "institution": "Dr. Babasaheb Ambedkar Marathwada University (BAMU), Aurangabad, India",
      "degree": "Bachelor of Pharmacy",
      "field": "Pharmacy",
      "endDate": "2011"
    }
  ],
  "skills": [
    "AI & Process Automation: Applying GenAI, RAG and workflow automation to pharmaceutical use cases",
    "Problem Solving: Identifying repetitive manual processes and developing practical technology-based solutions",
    "Regulatory Documentation: Strong attention to document structure, accuracy, consistency and compliance requirements",
    "Cross-functional Thinking: Ability to connect pharmaceutical requirements with technology and automation",
    "Continuous Learning: Actively developing skills in AI, automation, regulatory intelligence and digital transformation",
    "Analytical Approach: Able to break complex processes into structured steps and identify opportunities for improvement",
    "Adaptability: Comfortable learning new tools and applying them to unfamiliar pharmaceutical workflows",
    "Attention to Detail: Important for safety data, regulatory documents and quality-focused pharmaceutical processes."
  ],
  "languages": [
    {
      "language": "English",
      "fluency": "professional"
    },
    {
      "language": "Hindi",
      "fluency": "Native"
    }
  ],
  "certificates": [
    {
      "name": "Hands-On eCTD Preparation and Submission"
    },
    {
      "name": "Advanced Certification Course in Clinical Research, Clinical Data Management, Pharmacovigilance, Medical Writing, and Regulatory Affairs"
    },
    {
      "name": "AI Accelerator Program – Generative AI & AI Agents"
    },
    {
      "name": "Generative AI Mastermind – Out skill"
    }
  ],
  "availability": {
    "status": "open"
  },
  "ats": {
    "keywords": [
      "REGULATORY AFFAIRS EXPERIENCE",
      "PHARMACOVIGILANCE EXPERIENCE",
      "Yashfin Consulting Services",
      "AI & AUTOMATION EXPERIENCE",
      "Pharmacy",
      "English",
      "Hindi",
      "Hands-On eCTD Preparation and Submission",
      "AI Accelerator Program – Generative AI & AI Agents",
      "Generative AI Mastermind – Out skill"
    ],
    "yearsOfExperience": 1,
    "seniority": "entry",
    "highestEducation": "Master's"
  },
  "verification": {
    "email": true,
    "platform": "freecv.org"
  },
  "i18n": {
    "primary": "en"
  },
  "meta": {
    "version": "1.2.2",
    "canonical": "https://livelink.cv/zumera-fatima/cv.json",
    "lastModified": "2026-10-01T06:59:32.753Z",
    "generator": "FreeCV.org"
  }
}