EDUCATION :
Degree and Date Institute Major and Specialization
P. G. Diploma in Clinicoregulatory and patents
March 2008 Pharmaceutical Experts Association (Pexa), Matunga Clinical research, Regulatory affair, Patents
Diploma in Anaesthesia January 2004 Grant Medical College & JJ Hospital, Mumbai University Anaesthesia
M.B.B.S April 2000 Rajiv Gandhi Medical college, Mumbai University Medicine & Surgery
H. S. C. June 1994 B.N Bandodkar College, Thane Science
Experience summary and Career profile :
Dates Organization Role
17th August 2009 to 29th October 2010 TATA Consultancy Services Operations Physician/Medical Reviewer
18th August 2008 10th August 2009 Watson Clinical Research Organisation, Belapur Principal Investigator
25th May 2004 – July 2008 BEST Medical Officer
May 2004 – July 2008 General Practitioner General Practitioner
January 2004October 2004 Lambda Clinical research Organisation (BABE studies) Contractual Physician
September 2001 December 2001 Primary Health Centre, palghar Medical Officer
Previous Positions :
TATA CONSULTANCY SERVICES from 17th August 2009 to 29th October 2010.
DESIGNATION : Operations Physician /Medical reviewer
Project Title :Roche drug safety
Description : Drug Safety
Role Operations Physician :
Additional profiles within drug safety Drug Safety Associate
Responsibilities as a OPS Physician :
Responsible for the medical cohesiveness of single cases crossregionally in line with regulatory requirements.
Responsible for reviewing periodic reports and providing medical support to the medical writers in the preparation of periodic reports (as applicable).
Developing and maintaining knowledge of different disease biology areas for marketed drugs and drugs in development.
Responsible for the final medical review of adverse event reports, making decisions on SUSARs, and performing tasks such as writing Analysis of Similar Events.
Project ownership for crossregional collaboration to improve medical aspects of single cases.
Membership of global medical safety teams to influence strategic planning.
Working closely with global drug safety personnel to deliver training on the interpretation of single case reports, interpretation of laboratory data and other medical aspects.
Fostering close links with the Safety Science Group and other Regional Centres.
Developing relationships with other client functions and delivering efficient transfer and awareness of safety information.
Responsible for safety queries from Regional Centre and Affiliates.
Actively participates in Safety Team activities and Operations Physicians Meetings.
Delivering support to regional Marketing/Product Teams.
Proactively managing workload to meet very tight timelines.
Conduct/support single case data entry, assessment and medical review according to client SOPs and guidelines.
Collaborating with regional centres to support medical training.
Identifying trends in medical training needs and accountable for providing additional support and training
Assures business continuity/cover provision for single case processing
Responsibilities as a Physician :
1.Conducting Bioequivalence and Bioavailability studies for Watson Pharma Pvt.
Ltd. Till date conducted Twenty Pivotal studies and Thirty six pilot studies as PRINCIPAL INVESTIGATOR and participated in other fourteen pivotal and twenty pilot studies.
2.Management & evaluations of adverse events during the study.
3.Ensure safety and wellbeing of subjects during the trial.
4.Reporting of AEs and SAEs to Ethics Committee and Sponsor.
5.Managing all job function of clinical operations department.
6.Preparation and quality check of SOP’s as per regulatory guidelines.
7.Working in confirmation to SOP’s, GCP and GLP.
8.Conducting SOP training for clinical operation staff.
9.Quality check of protocols, reports and relevant SOP’s.
10.Quality check for project books, log books, instruments calibrations
11.Monitoring of BABE’s studies.
Assigning job responsibilities to clinical staff for smooth functioning of the department.
Screening :
Screening of Subjects
Evaluation of Pathological reports
Enrolling subjects in BABE Study
WATSON PHARMA PVT. LTD. :
DESIGNATION : Assistant Manager Clinical Operations
Poject Title : WATSON Clinical research Organisation
Description : Conduct of Bioequivalence studies
Role :Investigator
Additional profiles within CRO Assistant Manager Clinical Operations
Organisation B.E.S.T. :
Department :Medical
Role :Medical Officer
Responsibilities as a Medical Officer :
Handling burn, accident cases
Routine medical checkup of employees.
Medical examination of recruits.
General OPD
Sanctioning medical reimbursement of employees
Declaration :
I hereby declare that the above information provided is true to the best of my knowledge.
Signature :
Date :
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