Dr. Diksha Agrawal
Bangalore
Summary
Personable and detail-focused individual with strong foundation in pharmaceutical sciences and commitment to ensuring drug safety. Knowledgeable about drug safety regulations and adverse event reporting, with keen ability to analyze clinical data and identify potential safety concerns. Dedicated to contributing to patient safety and enhancing overall quality of healthcare through diligent monitoring and reporting.
Overview
2
2
years of professional experience
Work History
DRUG SAFETY ASSOCIATE
SITERO SOLUTIONS PVT LTD
05.2024 - Current
- Managed Adverse Event Case Entry, Coding, and Narrative Writing for ICSRs- Accurately entered adverse event case details into the safety database, ensuring proper coding of events and the creation of comprehensive Individual Case Safety Reports (ICSRs) for both serious and non-serious cases
- Conducted Literature Reviews to Identify Minimal Safety Information - Performed systematic literature reviews of medical literature, abstracts, and full-text articles to identify key safety data and company suspect drugs relevant to pharmacovigilance activities
- Initiated Full-Text Article Requests - Identified the need for full-text articles during literature review processes and collaborated with cross-functional teams to request and procure relevant scientific documents for in-depth case evaluations
- Developed and Maintained Drug Safety Files and Tracking Systems - Established and regularly updated drug safety files and tracking systems to ensure timely case management, accurate reporting and efficient document control within a pharmacovigilance framework
- Prioritized Adverse Event Cases Based on TAT and Regulatory Due Dates - Prioritized case processing to meet turnaround time (TAT) and regulatory deadlines, ensuring compliance with regulatory submission requirements and timely reporting of adverse events to health authorities
- Performed Evaluation and Case Processing of Serious and Non-Serious Reports - Managed the evaluation and processing of serious and non-serious adverse event reports, including spontaneous reports and post-marketing surveillance studies (noninterventional studies) within ARISg
- Evaluated Causality and Listedness for Serious and Non-Serious Cases - Assessed causality and listedness of adverse events, ensuring appropriate drug safety risk assessments and providing recommendations for case classification based on pharmacovigilance standards
- Conducted Full-Text Literature Reviews for Safety Data- Engaged in detailed literature reviews of full-text articles to extract relevant drug safety information, contributing to the continuous safety surveillance of marketed pharmaceutical products
- Ensured Accurate Inclusion of Patient Information in Case Narratives- Ensured accurate and complete inclusion of patient information such as demographics, medical history, and clinical data in case narratives, ensuring compliance with regulatory requirements for ICSR submission
- Ensured Compliance with EMA, US FDA, and Other Regulatory Submission Requirements - Maintained regulatory compliance with EMA, US FDA, and other global health authority requirements for adverse event reporting, safety submissions, and internal quality systems for drug safety
- Verified Accurate Transfer of Data from Source to Database- Oversaw the data transfer process from source documents to safety databases, ensuring the accuracy, integrity, and consistency of case data for regulatory submissions
- Prepared and Supported User Acceptance Testing (UAT) for LitPro- Contributed to the preparation and execution of User Acceptance Testing (UAT) for LitPro software, ensuring the system's functionality aligned with drug safety case processing and reporting requirements
Clinical Pharmacist Intern
HCG Cancer Centre - P. Kalinga Rao Road
06.2023 - 08.2023
- Enhanced patient care by conducting thorough medication therapy management and providing appropriate recommendations.
- Reduced medication errors by diligently reviewing prescriptions for accuracy, drug interactions, and therapeutic duplications.
- Continually expanded clinical knowledge base by attending educational seminars, webinars, workshops, and completing self-directed learning modules.
- Provided exceptional customer service while addressing patient concerns regarding medications, side effects, or insurance coverage issues.
- Participated in quality improvement efforts aimed at enhancing overall pharmacy performance and patient satisfaction levels.
- Educated patients on possible drug interactions, potential side effects, and optimal methods of administration.
Education
Doctor of Pharmacy - PharmD
Geetanjali University
Udaipur01.2023
Skills
- Adverse Event Case Entry
- Coding
- Narrative Writing
- Literature Reviews
- Full-Text Article Requests
- Drug Safety Files Management
- Tracking Systems
- Prioritization
- Case Processing
- Causality Evaluation
- Listedness Evaluation
- Safety Data Review
- Patient Information Inclusion
- Regulatory Compliance
- Data Verification
- User Acceptance Testing (UAT)
- Strong communication skills
- Adverse event reporting
Timeline
DRUG SAFETY ASSOCIATE
SITERO SOLUTIONS PVT LTD
05.2024 - Current
Clinical Pharmacist Intern
HCG Cancer Centre - P. Kalinga Rao Road
06.2023 - 08.2023
Doctor of Pharmacy - PharmD
Geetanjali University
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