Shalu Thakur

Medical Writer and Pharmacovigilance professional with over 10 years of experience in drug safety, signal detection, aggregate reporting, medical review, clinical documentation, and quality assurance within regulated healthcare environments. Proven expertise in authoring, compiling, reviewing, and de-identifying high-quality medical and scientific documents, including safety reports, case narratives, literature summaries, clinical data reviews, training materials, and regulatory-style documentation. Skilled in supporting AI training initiatives by contributing original, expert-authored medical content, assessing AI-generated outputs for factual accuracy, clinical relevance, reasoning quality, completeness, safety, and adherence to user requirements.

Strong understanding of patient confidentiality, ethical documentation practices, multimodal medical documentation, and structured data presentation using text, tables, charts, figures, timelines, and diagrams.

Medical AI Evaluator & Medical Documentation Contributor at Freelance (2026-02 – Present)

• Prepare and curate original, expert-authored medical and scientific documents for AI training projects, ensuring content demonstrates authentic medical reasoning, depth, clarity, and real-world documentation standards.
• Develop and refine de-identified medical materials such as case-based summaries, clinical documentation, safety narratives, literature-based reviews, research-style manuscripts, and internal training guides in Word and PDF formats.
• Apply rigorous patient confidentiality, data de-identification, and ethical documentation practices by removing or generalizing protected health information, patient identifiers, institutional details, exact dates, and other sensitive information before submission.
• Create and review multimodal medical documentation that integrates narrative text, tables, charts, figures, timelines, flow diagrams, structured data, and explanatory notes to support diverse AI training scenarios.
• Evaluate AI-generated medical and scientific responses for factual accuracy, clinical relevance, reasoning quality, completeness, safety, guideline alignment, and consistency across large language models including ChatGPT, Gemini, and Claude.
• Provide concise written context, clarification notes, quality observations, and documentation summaries to support remote collaboration, traceability, audit-readiness, and high-quality AI model training outcomes.

Senior Medical Writer at Parexel International India Pvt. Ltd. (2023-04 – 2026-02)

• Wrote, reviewed, assessed, and quality-checked medical and safety documents using predefined quality standards, regulatory requirements, and internal review processes.
• Prepared, coordinated, and reviewed PBRERs, DSURs, INDSRs, RMPs, PADERs, ACOs, and other aggregate safety reports for regulated pharmacovigilance deliverables.
• Performed signal detection, validation, and evaluation activities using safety databases, literature database sources, clinical context, and structured evidence assessment.
• Conducted quality control reviews of safety reports, clinical overviews, safety evaluation reports, regulatory responses, and medical documentation for accuracy, consistency, completeness, formatting, and conclusions.
• Developed literature search strategies, reviewed medical evidence, and translated complex safety information into clear, concise, and traceable scientific content for decision making.
• Trained and mentored team members on pharmacovigilance processes, aggregate reporting, medical review expectations, quality standards, and documentation best practices.

Medical Writer II at Parexel International India Pvt. Ltd. (2021-04 – 2023-03)

Medical Writer I at Parexel International India Pvt. Ltd. (2020-07 – 2021-03)

Pharmacovigilance Analyst at Parexel International India Pvt. Ltd. (2017-11 – 2020-06)

Pharmacovigilance Scientist at Parexel International India Pvt. Ltd. (2016-01 – 2017-10)

Bachelor of Dental Surgery in Dental Surgery – MN DAV Dental College, H.P. University (2015)