Aishwarya Mandru
Bangalore
Summary
Detailed-oriented and dedicated Drug Safety Associate with 6 months of hands-on experience in pharmacovigilance and drug safety. Experienced in utilizing ARISg tool to ensure accurate and timely data entry and case processing. Seeking a challenging role in a Clinical Research Organization to leverage my skills in pharmacovigilance and contribute to clinical research excellence.
Overview
1
1
Certification
Work History
Drug Safety Associate
FORTREA
BANGALORE
01.2024 - Current
- Triage and classify ICSRs for report type, seriousness, causality, labelling and reporting ICSR according to regulatory requirements.
- Processed and reviewed adverse event reports, ensuring accurate and timely data entry into the pharmacovigilance database.
- Conducted initial assessment and triage of safety information, determining the need for follow-up and further investigation.
- Experienced in composing clear, concise and comprehensive case narratives
- Completion of remaining case data entry, including narrative or auto- narrative
- Experienced in using ARISg for adverse event case management and regulatory reporting.
- Prioritization of incoming cases for daily workflow management
Quality Review :
- Perform Quality Review of ICSRs after the data entry.
- Participate in project teams to improve ICSR quality
- Document the quality review results and provide feedback to relevant team members
- Identify trends in errors and help identify training need
Processes & Procedures:
- Comply with SOPs and Work Instructions (WI)
- Comply with Kenvue guidance documents
- Adhere with MedDRA coding dictionary and MedDRA Points to Consider
Education
M.Pharmacy (8.52 CGPA)
GITAM Institute of Pharmacy
Visakhapatnam06-2020
B.Pharmacy (7.55 CGPA)
Raghu College of Pharmacy
Visakhapatnam06-2017
Skills
- Pharmacovigilance Tool (ARISg Tool)
- Legal Case Processing
- Manual Narrative Writing
- Case Creation
- IRT Creation
- MedDRA coding and WHO Drug Dictionary
- ICH, GCP Guidelines
- Knowledge of regulatory affairs principles and regulations (FDA, EMA, ICH)
- Familiarity with regulatory submission processes and requirements
- Computer Skills: Microsoft Office Work and Outlook, Word, Power point, Excel
- Good Written and Verbal Communication
- Flexible and punctual to timelines
- EndNote software
- Pharmacology- Basic Knowledge of medical conditions including Cancer, Diabetes, Asthma, COPD, Hypertension, Covid-19 etc
Accomplishments
PUBLICATIONS: Enhancement of skin permeability with thermal ablation techniques: concept to commercial products. Drug Deliv Transl Res. 2021; 11(3): 817–841. DOI: 10.1007/s13346-020-00823-3
PROJECT: "Preparation and Evaluation of Simvastatin Polymeric Nanoparticles
OBJECTIVE: The aim of the study was to formulate and evaluate polymeric nanoparticles of Simvastatin by emulsification solvent diffusion method.
METHODS: The Simvastatin polymeric nanoparticles were prepared using the emulsification solvent diffusion method to improve drug solubility. Furthermore, drug content, solubility, particle size, surface charge and transmission electron microscopy of the prepared polymeric nanoparticles were evaluated.
RESULTS: The results showed that the drug content in polymeric nanoparticles was 86.4%. The polymeric nanoparticles were spherical with a smooth surface and uniform size distribution. The particle size was 268.4±2.6, the polydispersity index was ≤ 0.302, and the zeta potential was -33 ±1.67 mV.
Certification
CERTIFICATION COURSE : 3 months of an advanced certification course on the basic concepts and workflow in Clinical Research, Clinical Data Management, Pharmacovigilance, Medical Writing and Regulatory Affairs INSTITUTE’S NAME: CliniWings- Clinical Research Training Institute
Duration: Nov 2022 to Feb 2023
Languages
Telugu
First Language
English
Advanced (C1)
C1
Timeline
Drug Safety Associate
FORTREA
01.2024 - Current
M.Pharmacy (8.52 CGPA)
GITAM Institute of Pharmacy
B.Pharmacy (7.55 CGPA)
Raghu College of Pharmacy
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