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Envisage Mumbai : Medical Writer
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[QUOTE=srkgsk321;154042]Mr. Santosh R. Kumbhar [B. Pharm,] srk.gsk AT gmail.com Career Summary Goal-directed professional with significant 06 years of experience in Clinical sector. Keen insight into the needs and views of others – able to listen and identify issues/problem areas and form innovative solutions. Professional, personable and articulate in presentation simultaneously exceptional in Clinical trials, Bioavailability and Scientific writing. Core Competencies - Communication - Documentation/Writing - Flexible/Assertive - Motivator - Team Player/Leader Career Path & Professional Responsibilities Sr. Executive Macleods Pharmaceutical Ltd. Feb’ 08 – Till Date Clinical Research Associate – - Coordination with Sponsor’s. - Preparation, and review of Clinical Reports. - Coordination between internal departments before conducting the trial. - Preparation of Protocol. - Reviewing the Protocol, ICF, CRF. - Preparation and reveiw of SOP’s. - Design and develop CRFs - Reporting any adverse events to the physician/ PI occurs during the conduction of trial. - Verifying that data entered on to the CRFs is consistent & monitoring the archival of documents. - Monitoring the trial throughout its duration. - Obtaining the ICF of subjects before conduction of trial. - Translation of ICF. - Montoring and reveiwing calibration records of all intruments and Equipments. - Allocation of duty to staff during conducting the study [b]- Pharmacy [/b]: Dispensing, Maintaining the Investigational Product and Operation of Humidity Control Oven. - Conduct routine monitoring - Maintain the study data. - Review of completed clinical data. - Completion of clinical data for submission to regulatory authority. - Archive the clinical data study files. - Train and mentor new people. Sr. Officer Watson Pharma Pvt. Ltd. (Dec’ 04 – Feb’ 08) Clinical Research Associate – - Preparation, review and design of protocols for clinical studies. - Prepare and review informed consent forms - Design and develop CRFs - Conduct study initiation - Allocation of duty to staff during conducting the study. - Preparation of SOP. - Monitoring Pharmacy related activity. - Conduct routine monitoring - Maintain the study data - Assist in clinical data review and correction - Review of completed clinical data - Completion of clinical data for submission to regulatory authority - Archive the clinical data study files - Monitoring the screening activity during the trial. - Monitoring the archiving of study documentation. - Train for operating ‘SAP’ Software. - Train and mentor new people - Monitoring handling of Waste Disposal. - Monitoring the trial throughout its duration. Production Co-ordinator Elder Pharmaceuticals Ltd. Mumbai (Jul’ 04 – Oct, 04) Production Coordinator – - Ensuring effective service levels and delivery. - Constant co-ordination with various departments to discuss and resolve operations related issues. - Ensure quality of product through well defined processes and personal monitoring - Monitoring and maintaining qualitative standards. Audit Faced 1. USFDA 2. ANVISA 3. ISO 4. DCGI 5. WHO 6. MCA Education Post Gradute Diploma in CRO Prin K.M.K College of Pharmacy, Colaba Mumbai 2006 Bachelor of Pharmacy Prin. K.M.K. College of Pharmacy, Mumbai University 2003[/QUOTE]
