M Kashaan_01 Oct 2016
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Dr. Mohammad Kashaan has over 4 years of experience in pharmacovigilance, regulatory affairs, and clinical research. He holds a Bachelor's in Dental Surgery and a Master's in Clinical Research. His skills include processing adverse event reports, database management, and ensuring compliance with regulatory guidelines. Currently he works as an Independent Quality Reviewer at Cognizant Technology Solutions, where he leads a team of 30 associates and publishes monthly quality reports.
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- 1. M Kashaans Resume Contact: +917738174509, E-Mail: kashaan.sidslr@gmail.com, ks.sidslr@outlook.com Basic & Discipline: Bachelors of Dental Surgery & M. Sc in Clinical Research. Specialization- Pharmacovigilance, Aggregate reporting and Regulatory Affairs. Total Experience: Approx. 4 years Professional Summary: An educational background in clinical research (pharmacovigilance) with bachelors of Dental Surgery. An agenda to secure a challenging position in an organization that offers professional growth while being flexible, resourceful and innovative. Personal Details: Full name: Dr. Mohammad Kashaan Date of birth: 16 January 1989 Address: LA 4/10, Cosmopolitan Housing Society, Takka, Panvel, Navi-Mumbai, Maharashtra- 410206 Email address: kashaan.sidslr@gmail.com Telephone no.: +91-7738174509 Skills/Knowledge and abilities (General and domain specific): Answer any pharmacovigilance related enquiries from external customers, such as health care providers (HCP/Non-HCP) or patient Independent quality review of the pharmacovigilance specific deliverables (Serious and non- serious ICSR processing, Spontaneous-Clinical trial ICSRs). Lean six sigma yellow belt. Well versed with six sigma ideology in order to ensure process and business excellence. Collection, documentation, quality reviewer and following up of all adverse events within area of responsibility from all sources including reports related to pregnancy, breastfeeding, lack of
- 2. efficacy, suspected transmission of infectious agents, overdose, abuse, misuse and medication errors. Database familiarity- ARGUS, APEX, SCEPTRE. Regulatory guidelines knowledge- ICH-GCP, HIPAA, 21-CFR Part 11, Schedule Y and other regulatory norms. To monitor general PV compliance incl. non-conformance reports and support management review meetings Strong communication skill in English (certified ILETS), URDU and Hindi, specialized skills in Microsoft word, excel, PowerPoint, access and project. Experience and knowledge in E2B format electronic data remediation and data basing. To support creation, maintenance, review and implementation of the local/regional/global Pharmacovigilance related procedures. Work Experience: April 2016 to current Company- Cognizant Technology Solutions PVT LTD Designation- Independent Quality reviewer/Senior Process Associate- Transactional Quality Assurance Team (Pharmacovigilance) (Quality lead) Brief Job description- Quality check on the operational quality reviewers. Act as an auditor for the pharmacovigilance operation team and direct reportee to the pharmacovigilance client. Publishing monthly /fortnightly quality report to the whole pharmacovigilance organization and client highlighting Standard Met Accuracy, Unit based accuracy (UBA) and Opportunities based accuracy of the whole team and individual associates. Team size handled- QUALITY LEAD for the team of 30 which includes pharmacovigilance case processors/ Data entry associates and quality reviewers. December 2014 to April 2016 Company- Quintiles Designation- Associate Operation Specialist Brief Job description- Intake and triage of the initial receipt of the source document from spontaneous, clinical trial post marketing studies. Case processing experience in serious-non serious and Solicited-unsolicited cases. Familiarized with processing of clinical trial (Phase 1, 2 and 3) and post marketing (phase 4) cases. Subject Matter expert in handling of clinical trial cases and triage. Team size handled- 5 January 2012 to June 2013 Company- Agrawal Dental clinic Designation- General Dental Practitioner
- 3. Brief Job description- Treatment provision to the dental and oral health patients. Routine oral health prophylaxis and patient care. Team size handled- NA Hobbies and Interests: Adventure sports like white water rafting, parasailing, scuba diving and hiking. Travelling new places to explore food and lifestyle. Educational Particulars: Name of Degree Name of Board/University Year of Passing Bachelors of Dental Surgery College of Dental Sciences, Karnataka, India 2012 65 %, excelle Class of 12th CBSE, Kendriya Vidyalaya, 2006 Class of 10th CBSE, Kendriya Vidyalaya 2004 Projects undertaken: Electronic Informed consent- We as team made an audio video version of the informed consent process specific to clinical trial recruitment process. As clinical trials understanding is complex and tedious one, it becomes very difficult for the patients to get familiarize with the overall process and willingness to give their consent. Quality feedback mail automation (In progress) Certifications in: English language (ILETS) Skill enhancement
- 4. Statistical Analysis system Reference: References are available upon request. Declaration: I hereby declare that the furnished details are true and authentic. Yours Faithfully, M Kashaan Date: 16/07/2016 Place: Mumbai, India.