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CURRICULUM VITAE
Dr. Krunal M. PatelM.Pharm, PhDResearch Associate Email: [email protected] , [email protected] Mobile no: 09726056996, 09879738461
Career Objective:
To succeed in an environment of growth and excellence and earn a job which provides me job satisfaction and self-development and help me to achieve personal as well as organization goals.
Total Experience: Above 1 year
Professional experience at glance:
Currently working as Research Associate as (Pharmacovigilance: Quality Reviewer & Regulatory submission) in Lambda Therapeutic Research Limited, Ahmedabad from March-2014.
Specialties: Pharmacovigilance, Quality check for ICSR, PVG In-house database validation (PQ), PV SOP writing and User rights management in the Pharmacovigilance database.
I have an exceptional eye for detail. My exposure to MHRA and USFDA inspections has given me hands on experience to obtain an enhanced level of understanding to meet the requirements to achieve a robust pharmacovigilance system. My role have also allowed me to improve my management skills which I have developed with the responsibilities of both project and people management.
I possess effectual oral and written communication skills and work well in pressured environments. I thrive as both a team member and individually. I have exceptional organizational and planning skills. I am a well motivated individual and work well within predefined timelines and under pressure. My research has also helped me gain the ability to demonstrate excellent attention to detail; self manage my projects and time and also make accuracy the utmost importance in all that I do.
Possess knowledge in the Regulatory affairs, Global Regulatory Bodies, Application of pharmaceutical sciences to product development, Process validation, Process control, Quality assurance and Quality control, in the pharmaceutical industry.
Knowledge of Good Pharmacovigilance Practices, CIOMS, Medwatch, ICH(E2B), ICH GCP (E6), MedDRA and regulatory requirements of USFDA, MHPD and other pharmacovigilance guidelines.
Educational Qualifications :
Ph.D (Pharmaceutical Sciences) from Jodhpur National University ♦ December-2012
M.Pharma from R.C. Patel College of Pharmacy ♦Shirpur, Dhule ♦2009 ♦66.75%
B.Pharma from Shri Bhagwan College of Pharmacy, Aurangabad ♦ 2007 ♦66.28%
Additional Qualification
Qualified GATE in 2007 with a score of 90% and received scholarship from AICTE, Delhi.
Industrial Training: Successfully completed an Industrial Training at Zydus Cadila
Healthcare Ltd., Ahmedabad for a period of 9 months.
Academic Projects:
Successfully completed Projects on Development, formulation and evaluation of chewable
tablets containing anti asthmatic drug (During M. Pharma) and Design development and
evaluation of modified release tablets containing Montelukast sodium (During PhD.)
Experience :
Oraganization: Lambda Therapeutic Research Limited, Ahmedabad
Designation:Research Associate (Pharmacovigilance)
Duration: From Mar-2014 to present
Roles & Responsibilities:
Quality reviewer (Experience with three database: AERS. ARGUS and PvNET)
Performs quality control on ICSRs and feedback of any observation to the individual who processed the ICSR. Where there are disputes, these should be escalated to the appropriate Line Manager.
Regulatory Submission
Submission of ICSRs to Regulatory authority via Electronic and paper format (e.g.Eudravigilance, ESG- USFDA etc) in accordance with company’s controlleddocuments (e.g. SOPs, WIs, Guide) and guidelines.
Submission/ lock of cases. Registration of client with Regulatory Authority for electronic submission. Receipt of regulatory cases from Eudravigilance. Registration of client’s product on EVMPD.
xEVMPD (Extended Eudravigilance Medicinal Product Dictionary) expert
Provide guidance and planning in registration of medicinal products or substances on xEVMPD.
Responsible for overall execution of xEVMPD projects. Ensuring that client’s medicinal products or substances are registered on xEVMPD in
defined time frame. Supporting the electronic submission of medicinal product information through Web
trader. Knowledge of detailed guidance on electronic submission of information on medicinal
products for human use by MAH to EMA.
Case Processing (Experience with three database: AERS. ARGUS and PvNET)
Case processing (spontaneous, regulatory and literature cases for drugs and cases for medical device) including duplicate check, data entry, drug coding, MedDRA coding, listedness, assessment for expediting, narrative writing in accordance with companies controlled documents (e.g. SOPs, WIs, Guide) and guidelines
Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality.
Identifying missing information and sending queries to provide accurate and complete available information.
QC of the cases and to verify with the source documents whether the case has been entered appropriately.
Additional Responsibilities
Preparation, revision, review of SOPs, Wls, templates, guide and guidance training documents
Communication of urgent safety issues to Line manager and QPPV Ensure communication with all relevant people is of a high professional standard, and that
records of both internal and external communication are maintained Ensuring compliance (quality, procedures, regulations, timeliness, consistency) with local
regulations and Company global Pharmacovigilance requirements Deliver training to new joinee and team as per requirement Work with the Aggregate Report/ ICSR team leader to escalate issues or tasks outside the
normal scope of work. Support group leader for timely submission of ICSR in order to achieve 100% regulatory
compliance
PUBLICATIONS
Pharmacovigilance: An Important Tool In Post Marketing Survelliance published in International Journal of Universal Pharmacy and Life Sciences 3(6): November-December 2013.
Preparation and evaluation of Gastro retentive Floating Tablets of Mebendazole published in international journal of current pharmaceutical research in Jan’ 11.
Preparation and Evaluation of sustain release Indomethacin tablets using skimmed milk and povidone published in International Journal of Current Pharmaceutical Research in Jan’ 11.
Publication on design, development and evaluation of modified release tablet of: Montelukast Sodium published in international research journal of pharmacy in Feb’ 11. Montelukast Sodium published in international research journal of pharmacy in Feb 2011. Montelukast Sodium by dry compression and tablet coating published in international
research journal of pharmacy in Mar’ 11. Montelukast Sodium by Pelletization compression and tablet coating published in
international research journal of pharmacy in Mar’ 11.
Preparation and evaluation Colon Specific Ibuprofen Tablets published in international research journal of pharmacy in Mar’ 11.
Preparation and evaluation Pulsatile Drug Delivery system containing Terbutaline Sulphate published in international research journal of pharmacy in Mar’ 11.
Preparation and evaluation of Gastro retentive Floating Tablets of Lansoprazole published in Journal of Pharmacy Research in Sep’ 10.
Preparation and evaluation of Sustain Release Ibuprofen Tablets using skimmed milk and HPMC published in Journal of Pharmacy Research in Sep’ 10.
Antimicrobial activity of different extract of Dolichost lab beans published in Research Journal of Pharmacognosy and phytochemistry in Aug - Oct 2009 edition.
Done a Paper Presentation on “Formulation and Evaluation of Sustain Release Ibuprofen Tablets using Chitosan and Acacia” at AICTE sponsored national seminar at RC Patel Institute of Pharmaceutical Education and Research.
Strengths and Skills :
Knowledge of Microsoft Office-Word, Excel, Power point and Internet Usage. Eudravigilance – EV Webtrader FDA ESG MedDRA dictionary eCTD knowledge Good communication skills, Team work and Confident
Personal Information :
Permanent Residential Address: B-204, Swaminarayan PresidencyCity Pulse theatre road, RandesanDist: Gandhinagar, GujaratPin: 382007
Date of Birth: 18-Jun-1986 Gender: Male Marital Status: married Language Proficiency: English, Hindi, Gujarati, Marathi
Declaration: I hereby declare that the particulars given herein are to the best of my knowledge and belief.
Date: Place: Ahmedabad Krunal M. Patel
