ANURADHA GANDHI

Edison, New Jersey,*****

646-***-****

ad0v7t@r.postjobfree.com www.linkedin.com/in/anuradha-gandhi Summary

Highly motivated and experienced clinical research professional with a strong background in pharmacovigilance. Proven ability to manage and process adverse event reports, conduct case reviews, and write regulatory reports. Expertise in using Oracle Argus Safety database, MedDRA, WHO-DD, and other pharmacovigilance tools. Skilled in data entry, coding, narratives and case analysis.

Skills

Oracle Argus Safety database.

Medical coding using MedDRA, WHO- DD (drug dictionary)

Daily Med, IME (important medical events) list.

PubMed, Vancouver Style citation.

Case narrative(analysis).

FDA-ICH (International Council of Harmonization) guidelines

GCP (good clinical practices) guidelines, GVP (good pharmacovigilance practices).

Proficient in MS Office (MS Word, MS Excel, Power Point) Professional Experience

Drug Safety and Pharmacovigilance, Sollers Institute,Piscataway,NJ (Sept 2022- Present)

AE reporting- generating case receipt number, case triage, data verification and validity check, case booking, registration, data entry.

Coding adverse events (AEs) / serious adverse events (SAEs) reports-laboratory data, relevant history, drugs (subject, concomitant, other medications if treated), events using MedDRA, WHO-DD.

Data entry of individual case safety reports (ICSRs) including general information, patient information, reporter information, medical history, laboratory data into Argus safety database.

Assess case reports for case validation, seriousness, expectedness researching USPI and Important Medical Event (IME) list and Daily Med.

Ensure duplicate check using global safety database and ARGUS for all ICSR existing case files. Perform causality assessment using WHO-UMC system.

Write case summaries of gathered information into concise, comprehensive- clinical narratives in correct format with right medical terms, verbatims using excellent English vocabulary, grammar.

Ensure accuracy and completeness within specified timelines.

Correct population into Oracle Argus from medical journal abstract, full literature articles by using PubMed Vancouver Reference Style -citation (title, journal, date of issue, volume, primary author, author in correspondence, their contacts).

General queries to obtain missing case information and clarifications if required in electronic data capture.

Understanding of Investigational Brochure (IB) and Information Consent.

Basic knowledge of an overview of SOPs of drug from its requirement- discovery, modification, development of a drug and post-marketing surveillance, aggregate reports, IND, NDA, ICSR, DSUR, PSURs /PBRER in compliance with regulatory authorities.

Perform quality reviews for AEs and SAEs, SUSARs (suspected unexpected serious adverse reaction).

Handling safety data.

JMI,JMP schools : Voluntary services

(2022-2023)

Planet Spark : English language specialist.

(2021-2022)

Trained students to speak in English confidently in public in a correct pitch, with appropriate body language having good knowledge of the content.

Vaidurya life sciences: dossier, medical writer.

(2013-2020)

Worked on some articles of pharmaceutical products- their active ingredient, action, adverse events related with them, their prescribed treatments, precautions. To find their authorization, manufacturers, brand names, generic names, how any biologics or drug can boost or interfere with human immune system.

MLS University :Associate (2010-

2012)

(1) Worked on PFGE with protein biomarkers to separate DNA fragments-to Identify disease causing alleles in person’s DNA-analyse gene associated with particular illness, (2) Saras Dairy for three months for examining the quality of milk, which can be easily deteriorated and contaminated due to faults by workers or environnemental status by microbial (bacterial fungal, yeast, mould) growth, (3) mushroom cultivation- cultivation of button mushroom (Agaricus bisporus-edible basidiomycete mushroom), (4) preparation of vermicompost to check and compare the fertility of soil and found that earthworms present in soil consume all kind of kitchen waste and hence make the soil very fertile with their saliva and excretory waste, (5) amount of oxalate ions in Guava in its under ripened amount is few and its sour in taste as it ripens, the amount increase and it tastes more better. Education

Certificate programme - Drug Safety and Pharmacovigilance, Sollers Institute

(Sep 2022- Present)

Certificate courses in Drug discovery, drug development from University California

(2020-2021)

Master Of Science (Biotechnology) from MLSU University, India

(2010)

Bachelor Of Science (Biotechnology) from MLSU University, India

(2008)

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