Kaisar Shaikh

Experience

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  Tnmc & Byl Nair Hospital Mumbai

  Jan 2011 - Mar 2012

  Junior Research Fellow

  Clinical Trial Coordinator/ Clinical Pharmacist for 3 projects:Project 1: BK83 Oral Nutrition Supplementation (ONS) in hospital inpatients (Sponsored by - Abbott Nutrition)Project 2: Painmukti study in patients suffering from chronic pain (Sponsored by - Ayushakti Health Care Pvt Ltd.)Project 3: Azithromycin study (Phase IV) To compare tolerability and efficacy of Azithromycin 2gms ER single dose with conventional multiple daily dose formulation Recording Medical Case History during Therapeutic Drug Monitoring (TDM) –OPD) and help in TDM documentation Reporting of Adverse drug reaction (ADR) on CDSO-ADR forms. (Pharmacovigilance) Conducted an Observational study (Survey) to “Assess Knowledge & Attitude of Ayurveda Professionals regarding Ethics Committees” Achievements & Profile Highlights : Initially joined as Trainee (full Time) and Completed 4 months internship (from1st Sep 2010 to 31st Dec 2010) in Clinical Pharmacology Department of BYL NAIR CHARITABLE HOSPITAL, Mumbai central, India and looking at my work I was offered Research Fellowship.Actively participated in Department personnel trainings & in the organizing workshops and their managements Patient Counselling activities عرض أقل

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  Noor specialist Hospital

  Jan 2013 - Apr 2013

  Hospital Pharmacist

  Inventory of drug products Assist in Dispensing drugs to Patients according to doctor’s Prescription Instructing to patients on how to use medications, possible side effects and storage Achievement-Initially joined as trainee to learn the Hospital Pharmacist work and after looking at my work I was recruited for the Pharmacist Job within a month

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  Bahrain Pharmacy & General Store B.S.C (c)

  May 2013 - now

  Analysis the product based on the local regulations requirements and classifying the items for proceeding with is registration and importsArranging and compiling the dossiers as per local regulations and timely submission of the dossiers to local Health Authorities for registration, renewals, variations, manufacturing sites for Pharmaceuticals, Health products, Functional Food, Medical devices, Cosmetics.Providing Regulatory Assistance to all Principal company with regards to Local Health Authority RegulationsHandling Innovators and Generic products regulatory submissions Communicating with HA & maintaining Good professional RelationshipAssist in Shipment clearance for Pharmaceuticals ( Tender & Non Tender products), Health Products, Medical devices, Cosmetics, Functional Food.Gathering Regulatory Intelligence from all Health Authorities and its timely dissemination to Principal companiesAssisting In Pharmacovigilance related obligation of the company Achievements & Profile Highlights-Within a year of Joining, I was facilitated a “Letter of Appreciation” by the higher management of the company due to my Dedication and hard work which contributed very positively in the growth of Regulatory Department and Business of our company.Handled a huge portfolio successfully – Medicines (started with 200 Medicine products currently handling 450 medicines regulatory activities with NHRA)Contributed positively in the establishment of the Pharmacovigilance System Extensive knowledge in the GCC regulations for Pharmaceutical products & regulatory documents of SFDA, EU, USFDA, UK -MHRA… Hands on experiences with Innovators products (Pfizer, Sanofi, Abbott, Mylan, MEDA, Bayer, Viatris, Acino, Baxter, Actavis, Cinfa, Merck…) & Generics (Kuwait Saudi Pharmaceuticals, NPI-Oman, DEEF Pharmaceuticals, TQ Pharma, Life pharma…..)Knowledge of GSO guidelines for consumer items and Medical device regulations worldwide عرض أقل

  • Regulatory Affairs Executive and Deputy Pharmacovigilance In charge

    Aug 2017 - now

  • Business Development and Regulatory Affairs coordinator

    May 2013 - Aug 2017