Irfan Shaikh
Mumbai
Summary
To learn, perform and grow in a challenging environment. To work sincerely with commitment towards work and acquired skills. To seek a great opportunity in the field of Pharmacovigilance and Clinical Research so as to utilize my skills for the Organization and for Individual growth.
Overview
8
8
years of professional experience
Work History
Senior Process Associate
TATA Consultancy Services
Mumbai
06.2018 - Current
▪ Quality check of the financial disclosure forms and IND forms as per Quality checklist.
▪ Updating of the financial interest information in financial disclosure applications.
▪ Updating system Clinical Trail Monitoring System.
▪ Generation and Quality check of Food and Drug Administration Financial Disclosure Report, Transparency Data Operation Reporting reports.
▪ Meeting project timelines and quality standards set up by the internal client.
▪ Handling compound submissions.
▪ Reviewing of Site close-out documents and Generation of Study end reports as per the regulatory specification.
▪ Monitoring of study milestones and Generating of Study close-out reports as required by FDA submissions.
▪ Ensuring compliance with ICH-GCP guidelines.
▪ Quality Checking of all Clinical Trial related document (Investigator Agreements, Consent Documents, Financial Disclosure forms, IRB Letter, Ethics committee approval, Curriculum vitae of Investigators, IP Accountability, Dispensing and Destruction Log, Delegation of Responsibility Report, Lab Documents)
▪ Update and maintain the data with accuracy and integrity within all relevant systems.
▪ In addition, maintain a log of M&D activities and verify that all CTMS access has been authorized.
▪ Audit/ Inspection Readiness: Timely review of eTMF (Country & Sponsors Master File) and updating & maintaining the Sponsor specific systems to keep the study Audit Ready.
▪ Electronic Archival of Study documents: Assist Sponsor & sites for the electronic archival of study document at the end of the study.
▪ Organize and participating in all appropriate meetings with Client.
▪ Preparation of Study status, metrics, various other reports and process related trackers.
▪ Mentoring new associates joined to the process and resolving their issues and concerns.
▪ Performs interim eTMF exports / uploads for the Study when applicable.
Scientific officer
Metropolis health care
Mumbai
06.2016 - 06.2018
- Screening of Blood Karyotype cases
- New Laboratory Technique, Research and Validation along with Head Supervisors
- Maintaining Audit related Documents up to date and ensuring smooth working as per Guidelines
- Technical Skills: Karyotype (BLOOD, BONE MARROW) FISH (BLOOD, BONE MARROW, AMNIOTIC FLUID, POC MULTIPLE MYELOMA).
Education
M.Sc, Distinction - Botany
Mumbai
08.2016
T.Y.B.Sc, Distinction - Botany
Mumbai
05.2014
H.S.C., 2nd Class -
Maharashtra
02.2010
S.S.C., 1st Class -
Maharashtra
03.2008
Skills
- Review and understand study protocol
- Generate study related reports
- Coordinate with Business CDM study manager
- Reconciliation of eCRF data and vendor data
- Identify and address data discrepancies in clinical data
- Issue queries within clinical database for missing or erroneous data
- Perform UAT (User Acceptance Testing)
- Quality check financial disclosure forms and IND forms
- Update financial interest information in applications
- Update Clinical Trail Monitoring System
- Generate FDA Financial Disclosure Report and Transparency Data Operation Reporting reports
- Meet project timelines and quality standards set by internal client
- Handle compound submissions
Accomplishments
- Received several appreciations from client.
- Awarded "Star performer of the Month" for understanding the critically and delivering the work on time with quality.
- Successfully cleared CAP Audits on January 2017 in Metropolis health care with Team.
- Successfully cleared NABL Audits on January 2017 in Metropolis health care with Team.
- Successfully cleared PET examination on July 2017 from University of Mumbai
- Won the STAR award for outstanding performance of the year from metropolis at 14 August 2017 in Metropolis health care.
Activities
- Qualify for at district level inter University Research Festival Avishkar-2016 at C.K.T College.
- Participated for University level in University Research Festival Avishkar-2016 at S.I.E.S College.
- Participated in First Responder's training Programme in Disaster Management on 23rd Dec, 2010 organized United Way Mumbai
- Attend the workshop in the deliberation therein organized by BSE and Mumbai University 2010
- Participated in Yuva Diwas Conclave on 12 Jan 2013 at, University of Mumbai , Vidiyanagri campus held by University of Mumbai
- Participated in workshop on Accessing American library Information Resources organized by the American library Mumbai and R.J College on 8th Aug 2015
- Participated in International Conference on Electron Microscopy (EMSI-2015) 8th July 2015.
- 10th Annual conference on 'Wetlands for our Future: Sustainable Live hoods 'Organized by Pryavaran Dakshata Mandal Under the auspices of University of Mumbai 31st Jan 2016.
- Attended a workshop on "BIOTECNOLOGY" held at central Reference Laboratory, Metropolis Healthcare Ltd. 19th Feb 2016.
Personal Qualifications
M.sc
Proficiency Skill Sets
- Good communication skills in written and verbal both.
- Good in performing multiple Activities.
- Good Knowledge of ICH GCP guidelines and regulation.
- Result Oriented, Flexible, Quick Learner and eager to learn new things.
- Knowledge about MS-Excel, Word and PowerPoints.
Publications
Publish a research paper titled 'Preliminary Phytochemical Evaluation and Quantitative Estimation of Corosolic and Ursolic Acid from Psidium guajava L'. In World journal of pharmaceutical research Volume 5, Issue 3 1318-1327 ISSN2277-710.
Extracurricular Activities
Work as project assistant in biodiversity survey of Bhvale village near Bhivandi area. Work as project assistant in tree senses of Indian Navy campus across the various Location in Mumbai. Research Project Work Completed a project, Preliminary Phytochemical Evaluation and Quantitative Estimation of Corosolic and Ursolic Acid from Psidium guajava L.
Disclaimer
I hereby declare that the information given above is true to the best of my knowledge and belief.
Timeline
Senior Process Associate
TATA Consultancy Services
06.2018 - Current
Scientific officer
Metropolis health care
06.2016 - 06.2018
M.Sc, Distinction - Botany
Mumbai
T.Y.B.Sc, Distinction - Botany
Mumbai
H.S.C., 2nd Class -
Maharashtra
S.S.C., 1st Class -
Maharashtra
Similar Profiles
Vrunda ChindhadeVrunda Chindhade
HR Manager at Tata Consultancy Services, TCS, Tata Consultancy Services LimitedHR Manager at Tata Consultancy Services, TCS, Tata Consultancy Services Limited
Sreya BasuSreya Basu
Procare Analyst at Tata Steel(Tata Consultancy Services)Procare Analyst at Tata Steel(Tata Consultancy Services)
Arun VArun V
Program Manager at Tata consultancy services | Financial Ombudsman ServicesProgram Manager at Tata consultancy services | Financial Ombudsman Services
Naimish AgnihotriNaimish Agnihotri
Assistant Delivery Manager at Tata Consultancy Services, Global Shared ServicesAssistant Delivery Manager at Tata Consultancy Services, Global Shared Services
Suraj SethSuraj Seth
Assistant Manager – Direct Tax at CBV & Associates LLPAssistant Manager – Direct Tax at CBV & Associates LLP