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[QUOTE=Guest-IJT;111774][b]Name [/b]: ashishkapoor [b]Email [/b]: ashishkapoor1981 AT gmail.com [b]Designation / Skillset[/b] : pharmacovigilance officer Dear Sir/Mam, This is with reference to presenting my candidature for a suitable position.. I have done B.Pharm from Jamia Hamdard (Hamdard University) in 2004 and did my MBA (Pharmaceutical Management) from Jamia Hamdard in 2007, New Delhi. I would like to mention that I have a worked with RANBAXY RESEARCH LABORATORIES as Screening Assistant for seven months. And I have also undergone two months summer project with the same organization. I have two years of experience as the Executive in QA at Arch Pharma Labs, Gurgaon and also worked with Arbro Pharmaceuticals Ltd, New Delhi, as a Technical Coordinator. At present from 06Oct2009 I am associated with Wipro Ltd, as pharmacovigilance officer (senior associate) for the Pfizer Process in Pharmacovigilance (Drug and safety Department) and my job profile is case assessor. I am attaching herewith, a copy of my resume for your kind consideration. Regards Ashish Kapoor [u][b]Resume[/b][/u] : PHARMACOVIGILANCE/ CLINICAL RESEARCH PROFESSIONAL Seeking opportunities in Pharmacovigilance / Clinical Research & Development/Market Research in KPOs and pharma sector ________________________________________ PROFILE - Competent and diligent professional offering a comprehensive experience of over 4 years in Pharma sector. Currently handling the responsibility as Senior Associate-Pharmacovigilance Officer at Wipro BPO (a Divison of Wipro Ltd). - Earlier worked as Executive QA with Arch Pharma Labs, Gurgaon, Technical Coordinator with ARBRO PHARMACEUTICAL LTD. New Delhi and Screening Assistant with RANBAXY RESEARCH LABS (Clinical Pharmacological Unit) Noida. - Possessing core competencies in Pharmacovigilance (Drug Safety), Drug Safety Databases, Project training, Medical Monitoring & Safety Monitoring, Clinical Research. - Comprehensive experience conducting trials and scientific study of effects, risks, efficacy and benefits of pharmaceutical products. Proven ability in administering Quality Control procedures and well equipped Good Clinical Practices - Academically sound with M.B.A (Pharmaceutical Management) from Jamia Hamdard, New Delhi and B.Pharma from Jamia Hamdard, New Delhi. - Articulate communicator with a strong work ethic, continuously striving for improvement coupled with excellent administrative aptitude with an eye for detail and the commitment to offer quality work. ________________________________________ PROFESSIONAL EXPERIENCE WIPRO BPO (a Divison of Wipro Ltd) Since Oct’09 Senior Associate-Pharmacovigilance Officer - Spearheading efforts across verifying overall consistency of cases, assessment of solicited unrelated spontaneous non-serious cases in Argus.. - Involved in assessing the case with LOE and AT-RISK scenarios. - Entrusted with the task of Coding of events and indications through Med DRA coder. - Exposure in Coding of drugs by CDD &WHO DICTIONARY. - Accountable for completing, aligning or modify the narrative with the narrative template. - Solving the validation warning before routing to work flow. - Work in accordance of business requirement of Pfizer. - Review Adverse Events for Reporting & submit Safety Reports to regulatory bodies. Report patient safety data as expedited SAEs and Safety Reports. - Coordinating with different functional team members, e.g. team leaders, clinical data verifiers, and other health care professionals and QC’S for completion of various cases with accurate consistency and proper validation. - Successfully contributed knowledge and expertise to or lead assigned deliverables in the field of Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate. ARCH PHARMA LABS, Gurgaon Oct’07-Oct’09 [b](Arch Pharma Labs Limited is an ISO 9001 [/b]:2000 certified company, well known among select and discerning international customers) Executive QA - Shouldered the onus of monitoring & compliance of project starting from R&D to dispatch. - Execution and review of Design Qualifications /Installation Qualifications/ Operational Qualifications for Plant and machinery. - Reviewed manufacturing documents, Batch processing Records, Validations Protocols/Reports etc. - Credible for handling of local Authority audit. ARBRO PHARMACEUTICAL LTD. New Delhi May’07-Sep’07 [b](An ISO9001 [/b]:2000 registered company that provides research and development services, technical problem solving and contract analytical services to industry, government and academia.) Technical Coordinator - Managed external client relationships. - Handled samples for testing process. - Coordinated between various departments involved in testing process. - In charge of Management and maintenance of records. - Made presentation of test results to experts for approval. - Managed the process of submission of approved test reports to concerned organization. RANBAXY RESEARCH LABS (Clinical Pharmacological Unit) Noida Feb’05-Aug’05 Screening Assistant - Executed in process of recruitment and enrolment of volunteers at Clinical Pharmacological Unit. - Management of volunteers during screening at CPU. - Analyzed and evaluation of medical reports according to volunteer’s eligibility as per inclusion-exclusion criteria. - Obtained the Informed Consent Forms and signed documents from the volunteers - Monitored the studies that all the activities are conducted as per GCP, ICH guidelines and SOPs. - Deftly carried out the compilation and maintain of all the documents of BA BE studies. - Assisted, Facilitated and coordinated with Doctors, study coordinators involved in studies ________________________________________ EDUCATIONAL DEVELOPMENT M.B.A (Pharmaceutical Management), 2007 Jamia Hamdard, New Delhi B.Pharma, 2004 Jamia Hamdard, New Delhi 12th, 1999 CBSE, New Delhi Certifications - Professional Diploma in Clinical Research (PDCR) from Catalyst Clinical Services Pvt Ltd, New Delhi. - General course on “INTELLECTUAL PROPERTY RIGHT” from WIPO Trainings Underwent Ranbaxy Research Labs (Clinical Pharmacological Unit) NOIDA - To study the Initiation, Conduction and Completion of Bioavailability and Bioequivalence process. - To identify the various aspects of Study Coordination. - Analysis of the Managerial Personnel Behavior in Bioavailability and Bioequivalence studies. ------------------------------------------------------- [b]More Information about this submission and submitter [/b]:- ___________________________________________________ [b]Submission ID [/b]: 4203527 [b]Date & Time [/b]: 2nd Jun 2011 1:45 PM (UTC) [b]IP Address [/b]: 115.242.113.232 [b]Browser Info [/b]: Mozilla/5.0 (Windows; U; Windows NT 6.1; en-GB; rv:1.9.2.17) Gecko/20110420 Firefox/3.6.17 Predicted Country : India[/QUOTE]
