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 :
** Safety Database
** ARISg Version 8.0
** Regulatory requirements for field of Pharmacovigilance. (Module 4 & 5)
** Regulatory Affairs
** 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 i Sponsored links :
nformation 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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