Pallavi KolteEmail : pallavikolte1 AT gmail.comWork Experience :July 2013-present :
Junior Data Analystin Pharmacovigilanceat Cognizant Technology Solution Pvt. Ltd, Mumbai.May-June 2012 :
Intern inManufacturing/ Quality Control/Quality Assurance & Stores in parenteral department at Maneesh Export (EOU), Turbhe, Mumbai.Skills :
ARISg Version 8.0
Regulatory requirements for field of Pharmacovigilance. (Module 4 & 5)
Pharmaceutical Quality System,ICH Quality guidelines, ICH M4 Q CTD format
Drug substance section
DMF preparation : Module 2, Module 3; DMF Submission to USFDAs, Regulatory submission to Europe-(ASMF, CEP).
Drug product section
Dossier preparation in CTD format : Module 2, 3,4 & 5; ANDA approval processAcademics :Jun-Dec 2014 :
P.G. Diploma in Drug Regulatory Affairs (Institute of Pharmaceutical Management, Mumbai)2009 -2013 :
Bachelor of Pharmacy from NCRD’S Sterling Institute Of Pharmacy, MUWork Profile and Responsibilities :
To enter and review ICSR details regarding patient, event & drug information, medical history, associated lab data and reporter infor Sponsored links :
mation into safety database.
To code drugs by using WHO medical dictionary (WHO DD) with reference to ATS drug classification method.
To code adverse events, medical history, drug indications and lab data by using MedDRA(Medical Dictionary for Regulatory Activities) dictionary.
To perform Labeling, Causality and Assess relationship as per the cases.
To evaluate case information for medical completeness.
To write case narratives as per source document and medical judgment.
To review and modify the necessary case data in accordance with applicable SOPs.
Upgradea Non-Serious Case to a Serious Case, following the medical assessment.
To keep check on regulatory timeline for ICSR submissions and their requirements.Extra-Curricular Activities :
Participated in Innovative Campaign (Patient Health Awareness) organized by IPA’s Students’ Forum.
1st Runner up in ‘Debatonators 2012’ arranged by NCRD’s Sterling Institute of Management Studies.Personal Dossier :Date of Birth :Sept 3 1991Lingustic Abilities : English, Hindi, MarathiHobbies & Interest : Listening Music, Reading & TravellingMarital Status : SingleDeclaration :
I hereby declare that all the information given above are true and correct to the best of my knowledge and belief.Yours faithfully :
Pallavi Pradeep Kolte
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