SAKEER HUSSAIN
Calicut
Summary
Accomplished Clinical Research Assistant at JSS Hospital, adept in adverse event reporting and analysis, and exceptional in translating complex scientific data into accessible content. Proven track record in enhancing scientific credibility through meticulous literature reviews and collaborative research, underscored by strong analytical skills and effective communication.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Clinical Research Assistant
JSS Hospital
Mysore
07.2023 - 01.2025
- Authored and co-authored scientific manuscripts, abstracts, and review articles for publication in peer-reviewed journals, ensuring accuracy, clarity, and adherence to ICMJE, GPP3, and company guidelines.
- Collaborated closely with subject matter experts, researchers, and cross-functional teams to gather and interpret scientific data, translating complex information into accessible, high-quality content.
- Conducted extensive literature reviews to support the development of publication content, identifying relevant studies and incorporating recent findings to enhance scientific credibility.
- Managed the manuscript submission and publication process, including preparing submission packages, responding to peer-review feedback, and implementing necessary revisions.
- Proofread and edited drafts for grammar, scientific accuracy, and consistency, performing quality checks to maintain publication standards.
Pharm D Intern
JSS Hospital
Mysuru
07.2023 - 06.2024
- Collected, reviewed, and evaluated adverse event data to ensure accurate reporting and compliance with regulatory requirements.
- Conducted case processing, including data entry, coding, and assessment of adverse drug reactions using pharmacovigilance software (e.g., Argus, Oracle).
- Collaborated with cross-functional teams, including regulatory affairs and medical information, to support signal detection and risk management processes.
- Responded to inquiries related to drug safety and adverse events from healthcare professionals and patients, contributing to effective risk communication.
- Supported audit and inspection activities by ensuring data quality and regulatory compliance in all pharmacovigilance documentation.
Education
Doctor of Pharmacy - Pharmacy
JSS College of Pharmacy
Mysore06-2023
Skills
1 Adverse Event Reporting and Analysis
- Expertise in identifying, documenting, and reporting adverse drug reactions (ADRs) in accordance with regulatory guidelines
2 Data Collection and Management
- Skilled in gathering and managing safety data from clinical trials, healthcare providers, and patient-reported sources
3 Case Processing and Narrative Writing
- Skilled in composing clear and concise case narratives that summarize patient cases and adverse events for regulatory submissions
- Attention to detail in documenting patient history, adverse event details, and treatment outcomes
4 Analytical and Critical Thinking
- Strong analytical skills to assess case reports and identify patterns or trends in safety data
5 Communication Skills
- Ability to clearly communicate adverse event information to healthcare professionals, regulatory bodies, and internal stakeholders
6 Attention to Detail
- Meticulous attention to detail in data entry, documentation, and case processing to ensure regulatory compliance and accuracy
7 Technical Proficiency
- Familiarity with pharmacovigilance and clinical software, VigiBase, along with general proficiency in Microsoft Office (Excel, Word)
Affiliations
. Donepezil and memantine-induced second-degree atrioventricular block: A Case
Report
· A case report on dobutamine-induced multifocal myoclonus in a patient with severe
chronic kidney disease
· A case report on FOLFOX-induced severe hypokalemia with hypocalcemia and hypomagnesemia.
· Lipid-Lowering Therapy Associated with Erectile Dysfunction and Testicular Pain - A Rare case report
· A double whammy of takotsubo cardiomyopathy and severe hypernatremia in a patient with recurrent craniopharyngioma. -Communicated
.A case report on multiple sclerosis and atrial fibrillation: a rare and incompletely understood association communicated
.A successfully repaired lacerated brachial artery due to a gunshot wound.
Certification
- Current Regulatory Requirements for Conducting Clinical Trials in India for Investigational New Drugs/New Drug.
- Good Clinical Practices
Timeline
Clinical Research Assistant
JSS Hospital
07.2023 - 01.2025
Pharm D Intern
JSS Hospital
07.2023 - 06.2024
Doctor of Pharmacy - Pharmacy
JSS College of Pharmacy
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