Lakshmi Kanthamma Sairaj
Austin,TX
Summary
Detail-oriented Pharm.D. professional with a robust background in pharmacovigilance, regulatory compliance, and clinical documentation. Adept at preparing regulatory documents, authoring clinical study reports, and collaborating with cross-functional teams. Seeking to apply my expertise in medical writing and regulatory documentation in the Medical Writing role contributing to the development pharmaceutical products.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Clinical Pharmacist Intern
ESIC Hospital
India
05.2018 - 05.2022
- Assisted in providing clinical pharmacy services in a hospital setting, focusing on patient safety, medication therapy management, and drug information.
- Supported clinical pharmacists in the review and management of patient medication profiles, ensuring appropriateness and safety of prescribed medications.
- Participated in the preparation of drug monographs, patient counseling, and patient education on proper medication use.
- Conducted medication reviews and assisted in identifying potential drug interactions, side effects, and contraindications, ensuring patient safety and adherence to therapy.
- Collaborated with healthcare professionals including physicians, nurses, and other staff to optimize drug therapy outcomes for patients.
- Gained practical experience with pharmaceutical care, clinical documentation, and the application of evidence-based practices.
- Assisted in conducting therapeutic drug monitoring, especially for high-risk medications, ensuring proper dosage and preventing adverse drug events.
- Contributed to inventory management and procurement of drugs, ensuring the availability of essential medications for patient care.
Drug Safety Associate
IQVIA
Bangalore, India
09.2020 - 01.2022
- Authored and reviewed clinical safety reports and narratives, ensuring alignment with regulatory requirements and internal standards.
- Collaborated with cross-functional teams to ensure timely completion of regulatory documents and case processing for clinical trials.
- Conducted medical review and narrative preparation for adverse event (AE) and adverse drug reaction (ADR) reports, ensuring accuracy and regulatory compliance.
- Managed and analyzed safety data while adhering to industry regulations, internal guidelines, and projectspecific needs Proficient in using Argus and ARISg databases, MedDRA medical coding, and Microsoft Office Suite.
- Played a key role in document quality assurance, improving case report accuracy by refining internal processes and reducing errors.
- Demonstrated strong writing and communication skills in preparing and reviewing narratives, reports, and case documentation.
- Enhanced document timelines and cross-team collaboration, ensuring the efficient delivery of high-quality documentation.
- Conducted follow-ups on safety information and managed documentation of adverse events for regulatory submissions.
Education
Master of Science - Information Technology Management
Campbellsville University
Louisville, KY01.2024
Doctor of Pharmacy -
Vels Institute of Science Technology and Advanced Studies
Chennai01.2020
Skills
- Regulatory Document Preparation
- Medical Writing
- Clinical Documentation
- Pharmacovigilance & Case Processing
- Technical Proficiency
- Cross-functional collaboration
- Case processing experience
- Project management experience
- Strong communication skills
Certification
Certified in Good Clinical Practice (GCP), NIDA Clinical Trials Network
Additional skills and achievements
- Knowledgeable in ICH GCP, GMP, and regulatory compliance standards.
- Published over 5 articles in peer-reviewed journals, contributing to medical and scientific writing
- Presented at international and national conferences, enhancing presentation and writing skills.
Research and Thesis
1. Assessment of Cardiorenal Risk in Type 2 Diabetes Mellitus Patients Receiving Empagliflozin and Liraglutide Therapy.
2. Clinical Association of Serum Calcium Levels in Pre-eclampsia and Gestational Hypertension Patients - A Prospective Observational Study
Timeline
Drug Safety Associate
IQVIA
09.2020 - 01.2022
Clinical Pharmacist Intern
ESIC Hospital
05.2018 - 05.2022
Certified in Good Clinical Practice (GCP), NIDA Clinical Trials Network
Master of Science - Information Technology Management
Campbellsville University
Doctor of Pharmacy -
Vels Institute of Science Technology and Advanced Studies
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