Faizur Rahman

Experience

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  Comed Pharmaceuticals Limited

  Jun 2010 - Aug 2010

  Trainee Quality Contorl

  processing of quality control and production department in formulation of tablets and capsules.

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  Indraprastha Apollo Hospitals , New Delhi

  Jan 2012 - Jun 2012

  Clinical Research Coordinator Trainee (Internship)

  Worked as a trainee under MD doctor in Nephrology division. This is part of course curriculum. Learned about the practical aspect of Clinical trial like wise clinical trial procedure ICF process,IP Dispensing clinical trial data collection as per ICH GCP Schedule Y, and local applicable regulatory requirement. Case report form filling. IP dispensing to patient, Investigator file updation.etc

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  Apollo Hospitals

  Aug 2012 - May 2013

  Clinical Research Coordinator

  Handled Global Clinical Trials in different Therapeutic areas- Nephrology, Endocrinology, Oncology, Cardiology, Urology.Job Responsibilities:Responsible for Conducting clinical Trial and ensured that they are conducted in accordance with the protocol, standard operating procedures, good clinical practice as well as applicable regulatory requirements.Submission of study protocol and all related documents to ethics committee for approval.Involved in Investigational product management.Ensuring That all necessary data are gathered and recorded in the appropriate source documents i.e Case report forms.Resolving data queries. Concomitant medication review.Assisted in documenting of Informed Consent process (ICF). Case report form completion, paper CRF/eCRF.Medical history reviewManaging laboratory procedures (processing, packaging and shipping).Reporting AE and SAE occurred at the site to Ethics Committee and sponsor.Scheduling and coordinating patient visits as per trial related activities.Screening the patients for clinical trial.Assisted in protocol writing.Assisted in writing source document.Ensuring that study documents are complete, current and filed correctly. Show less

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  CliniExperts Services Pvt. Ltd.

  Jul 2014 - Sept 2016

  Regulatory Affairs Executive

  As a regulatory executive I have involved in Preparation of various regulatory applications like import licence, clinical trial/Global clinical trial application, bioequivalence study, manufacturing and marketing, export NOC, literature search, summary of drug-drug interactions, summary of pharmacological and toxicological data, review of chemical and pharmaceutical data, compilation of regulatory dossier for submission to Indian Regulatory authority ( CDSCO) office. Also Preparation of regulatory application for Import & Registration of Medical Devices and Cosmetics. Interacting with regulatory authorities to obtain approval, reply to regulatory queries, and follow-up for ongoing projects. Experience in Clinical Research and Regulatory field make me easier to understand regulatory requirement for new drug application (NDA) filling to CDSCO. Well understanding and live experience in “SUGAM online application System” implemented by CDSCO for filling of different types of applications. Well versed in Indian regulations, Clinical Trial Procedures, Marketing approval process for New Drug, Medical Devices and Cosmetics. Good Understanding on ICH, GCP CTD/ACTD, ASEAN and US FDA guidelines. Show less