KHUSHNIDA YASMEEN
Medical Writer
Vellore,TN
Summary
Detail-oriented M.Pharm (Pharmacy Practice) graduate with over 3 years of experience in Medical Writing and strong interest in Clinical Research. Experienced in preparing regulatory and clinical documents including CEP, PSUR, PMSR, PMCFP, and PMCFER in compliance with EU MDR, ICH-GCP, ISO 14155, and FDA guidelines. Skilled in literature review, clinical data analysis, risk-benefit evaluation, and post-market surveillance documentation. Adept at collaborating with cross-functional clinical and regulatory teams to ensure accuracy, compliance, and high-quality deliverables. Passionate about contributing to clinical research operations and advancing evidence-based healthcare practices.
Overview
6
6
years of professional experience
Work History
CLINICAL PHARMACIST
Naruvi Hospitals
03.2025 - Current
- Conduct comprehensive medication reviews and monitor therapeutic outcomes for inpatients and outpatients.
- Collaborate with physicians, nurses, and healthcare staff to design and optimize drug therapy plans.
- Provide patient education on medication usage, side effects, and adherence.
- Monitor and report adverse drug reactions and implement preventive measures.
MEDICAL WRITER
HCL technologies
10.2019 - 06.2022
- Developed and authored a wide range of regulatory and clinical documents such as PMSP, PMSR, PSUR, PMCFP, PMCFER, and CEP ensuring alignment with EU MDR, MEDDEV 2.7/1 Rev.4, and other international standards.
- Ensured regulatory and quality compliance by strictly adhering to applicable global guidelines (e.g., ISO 14155, GCP, FDA, EU MDR) and (SOPs). Maintained documentation integrity, traceability, and audit readiness throughout the document lifecycle.
- Collaborated closely with cross-functional teams including clinical research associates, safety and risk managers, subject matter experts (SMEs), and regulatory affairs professionals to gather, interpret, and validate data used in clinical documentation and risk-benefit evaluations.
- Contributed to successful project outcomes by meeting deadlines and maintaining high-quality standards.
Education
Master of Pharmacy - Pharmacy practice
Sri Ramachandra Institute of Higher Education And Research
chennai06-2019
Bachelor of Pharmacy -
Sri Ramachandra Institute of Higher Education And Research
chennai05-2017
Skills
Regulatory writing
Clinical documentation
Scientific documentation
GCP
Medical Device Regulations
Literature Review
Medical terminology
Clinical research
Regulatory science
Clarity and accuracy in documentation
Patient counseling
Adverse drug reaction monitoring
Medical decision-making experience
Drug utilization review
Additional Information
Advanced Program in Clinical Research & Management (APCRM)
Clini India | Currently Pursuing
- Comprehensive training in Clinical Research processes including clinical trial phases, ICH-GCP guidelines, regulatory requirements, ethics committee procedures, and trial documentation.
- Exposure to case report forms (CRFs), informed consent process, clinical trial monitoring, pharmacovigilance basics, and data management concepts.
- Practical understanding of sponsor–CRO–site coordination and clinical trial operations in India.
Value Added Course in Medical Genetics
Sri Ramachandra Institute of Higher Education and Research
Timeline
CLINICAL PHARMACIST
Naruvi Hospitals
03.2025 - Current
MEDICAL WRITER
HCL technologies
10.2019 - 06.2022
Master of Pharmacy - Pharmacy practice
Sri Ramachandra Institute of Higher Education And Research
Bachelor of Pharmacy -
Sri Ramachandra Institute of Higher Education And Research
Awards
- Business Champion - HCL Technologies, Chennai
- Knowledge Champion - HCL Technologies, Chennai
Personal data processing
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