ZUMERA FATIMA

Pharmacovigilance & Regulatory Affairs Professional | AI-Enabled Process Automation

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.

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Work Experience
REGULATORY AFFAIRS EXPERIENCE
Sep 2025 — Jan 2026
  • 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.
PHARMACOVIGILANCE EXPERIENCE
Yashfin Consulting Services
Feb 2023 — Aug 2025
  • 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.
AI & AUTOMATION EXPERIENCE
  • 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.
Skills
AI & Process Automation: Applying GenAI, RAG and workflow automation to pharmaceutical use casesProblem Solving: Identifying repetitive manual processes and developing practical technology-based solutionsRegulatory Documentation: Strong attention to document structure, accuracy, consistency and compliance requirementsCross-functional Thinking: Ability to connect pharmaceutical requirements with technology and automationContinuous Learning: Actively developing skills in AI, automation, regulatory intelligence and digital transformationAnalytical Approach: Able to break complex processes into structured steps and identify opportunities for improvementAdaptability: Comfortable learning new tools and applying them to unfamiliar pharmaceutical workflowsAttention to Detail: Important for safety data, regulatory documents and quality-focused pharmaceutical processes.
Education
Master of Pharmacy, Pharmacy
Dr. Babasaheb Ambedkar Marathwada University (BAMU), Aurangabad, India
Bachelor of Pharmacy, Pharmacy
Dr. Babasaheb Ambedkar Marathwada University (BAMU), Aurangabad, India
Certifications
Hands-On eCTD Preparation and Submission
Advanced Certification Course in Clinical Research, Clinical Data Management, Pharmacovigilance, Medical Writing, and Regulatory Affairs
AI Accelerator Program – Generative AI & AI Agents
Generative AI Mastermind – Out skill
Languages
English
professional
Hindi
Native
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