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Summary

Pharmaceutical Medicine professional with over 9 years experience in Clinical research & Pharmacovigilance •1.3 years of experience as a zonal pharmcovigilance officer controlled 2 regional and 18 peripheral Pharmacovigilance center in india under indian drug regulatory authority, central drug standard control organization (cdsco), www.cdsco.nic.in at department of Clinical pharmacology, kem Hospital mumbai. http://www.kem.edu/ •two years experience Principal Consultant to cosmo clin research (ccr), and four years experience in the 3-drugs / ccr site management organization (Outsourcing clinical drug development) •experience of conducting global trials with amgen,who, lambda therapeutics, emcure, ipca, quintiles •overall 38 projects on the Drug Safety research. •research ares: preventable drug harms, triggers to detect adverse drug events. •doctorate (phd) in the medical pharmacology, •doctorate (phd) in Knowledge ManagementFounder Member of the MSc. Pharmaceutical Medicine course in india, this course is conducting at only three places all over the world at the University of the surrey, italy and muhs •Member Secretary of the institutional Ethics committee and independent Ethics committee •more than 65 industrial Protocol evaluated till date as pharmacologist •more than 80 Phase IV Protocol wrote and guided. •demonstrable knowledge about Preclinical study, Toxicology study and complete Drug development process. •published 19 original research Publications on clinical and Drug Safety studies in the international peer reviewed indexed medical and Pharmacy journals. • team Leader: first prize in india under Health Science category: 2nd national Student research convention 2009: kolkata, bengal Engineering and science University, howrah. can speak danish

Experiences

Current Experience

  • Faculty (Visiting) MSc. Pharmaceutical Medicine (Clinical Research) Superspeciality of Medicine


    Since March 2007
    Training and development of medical professionals / Pharmacist for, 1.complete applied aspects Drug Development (pre-clinical to Phase IV) 2. Pharmacovigilance and Drug Safety: adrs monitoring, causality, preventability, Drug Safety data base, medical coding, icsr, psur, asr writing. 3. clinical science)" rel="nofollow">Protocol writing, crf preparation, icf writing, site initiation to study close out of the study the sites, e-crf filling. CRO and smos working, contract administration. 4. pre-Clinical pharmacology, clinical Molecular Pharmacology, general pharmacology Training and Development of Medical Professionals / Pharmacist for, 1.Complete Applied Aspects Drug Development (Pre-clinical to Phase IV) 2. Pharmacovigilance and Drug Safety: ADRs monitoring, Causality, Preventability, Drug Safety Data Base, Medical Coding, ICSR, PSUR, ASR Writing. 3. Clinical Protocol writing, CRF Preparation, ICF writing, Site Initiation to Study Close out of the Study the Sites, e-CRF Filling. CRO and SMOs working, Contract Administration. 4. Pre-clinical Pharmacology, Clinical Molecular Pharmacology, General Pharmacology

Past Experience

  • Clinical operation manager

    April 2011 --- January 2016
    developed and implemented Training plans to the Clinical Research Coordinator, Investigator and supporting staffs errorless working and quality Documentation. trained, supervised and evaluated clinical research coordinators and Research Assistant in the performance of their duties. update Training module and retrain study staff as required. accurately implemented ich gcp SOP for the sites as per trial specifications and sponsor requirement. assisted with the preparation of iec / irb Applications, including science)" rel="nofollow">Protocol and informed consents coordinated with sponsor and site for contract Negotiation and formulating Clinical Trial agreement. planned budget and resources for clinical study programs administered clinical operational plan and Budgets supervised efficient working of clinical and operational staff. developed business strategies to bring clinical projects from sponsors and designed study plans. evaluated required site regulatory documents. secured business relationships with Advertising vendors and worked with them to utilize monitored each sites essential documents (ed) as per the sponsor and regulatory requirement. participated in Operations meetings and provided Training as per the requirement. monitored study materials and assisted in shipment from site to site. maintained source documents and regulatory Documentation of Clinical Trial. ensured quality of data on crfs. monitored Health and safety of subjects with frequent contact and ensure subject Compliance with the study science)" rel="nofollow">Protocol. monitored adverse event Documentation to principal Investigator and sponsor where appropriate.

  • Zonal Pharmacovigilance Officer

    February 2006 --- April 2007
    •medical Reviewer for Pharmacovigilance (adverse case reports) and active involvement in various Pharmacovigilance activities. • perform medical review of Clinical Trial and post-Marketing individual case safety reports, and determine their regulatory reportability, to ensure appropriateness of medical content and MedDRA coding and accurate assessment of reporting requirements including expectedness/labeledness and causality. • provide articulate and scientifically valid medical assessment and Pharmacovigilance comments for each case. • work in close collaboration with safety Operations, initiate, and contribute to procedures for optimization of collection, Documentation, follow-up and coding of Adverse Events and improving medical review process. • development and review of internal Training material and Presentations for knowledge sharing. • involvement in various bd activities related to Life Sciences •preparation of the management information system report (mis) •causality Analysis, preventability, expectedness of icrs •reporting to the who uppsala adr reporting centre •electronic submission and reporting to the who •management of the progress of the regional and peripheral Pharmacovigilance centre •herbal pharmacovgilance: Analysis of the ayurvedic drugs for the adverse drug event

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAssertivenessAttention to detailCharmCommunicativeCoordinationEfficiencyFlexibilityIndependenceInnovative thinkingProblem solvingStrategic thinking

Knowledge

LinkedIn Assessment :
PharmacovigilanceCorporate ManagementPharmacoepidemiologyCorporate GovernanceCROClinical trialsClinicalPharmaceuticalsClinical researchRegulatory affairsBiotechnologyTalent AcquisitionExecutive SearchTherapeutic AreasOutcomes ResearchTeam LeadershipCancerPharmaceutical IndustryMedical writingGCPICH-GCPHospitalsVaccinesMedicineClinical DevelopmentLife SciencesPharmaceuticsmanagementHealthcareTrainingStrategyDrug SafetyResearchInformaticspharmacologyAnalysisProject ManagementClinical Data ManagementLeadershipSOPR&DCTMSStrategic PlanningConsultingDocumentationHuman ResourcesFDAMedical DevicesRegulatory submissionsQuality Control

Skills and Expertise

Self Assessment :
Analytical skills Build and manage the Trial Master File (TMF) Create SOPs Design case record forms Develop clinical trial protocols Develop protocols Guide students Interact with physiciansAdverse event reportingAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAssess site feasibilityAssist study siteAttend investigator meetingCollaborate with principal investigatorCommunicate with investigatorComplete case report form (CRF)Conduct post-marketing surveillance studyCoordinate ethics committeecoordinating research projectsDesign case record form (CRF)Design post-marketing surveillance studyDetermine availability of facilities and equipment at the siteDevelop ICH/GCP compliant processesDevelop regulatory strategyDiscuss treatments with investigatorEnsure consistency between the protocol and CRFEnsure good clinical practice (GCP)Ethics committee submissionsFinancial administrationImplement Quality Management System (QMS)Indentify clinicians to conduct clinical trialsInteract with ethics committeeManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage trial master file (TMF)Research at universitiesSet up a clinical studySite managementSolve problemsTrain on site staff

Education

  • Doctor of Philosophy (Ph.D.) in Knowledge Management from Rai University, Ahemedabad in 2015
  • Doctor of Philosophy (Ph.D.) in "Drug Safety Monitoring and Prescribing Patterns of Drugs" from Department of Pharmacology,Government Medical College, Aurangabad, MUHS in 2011
  • Masters In Pharmacology, MBA (HR), PGDPRAF, PGDIPR, PGDHRM, DIM, IDCRC, TelMed, IMM in Pharmacology from University of Pune in 2009
  • KG in from Rachana High School in 1990

Training and Certification

  • Research Methods, Clinical Research, Pharmacovigilance in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Danish
Elementary Proficiency
English
Native

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Clinical Operations Manager Clinical Research Associate (CRA) Clinical Research Consultant Clinical Research Manager Clinical Research Coordinator Clinical Safety Associate
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    10% FTE
    BrightOwl freelancer :    6 Hours per week
    BrightOwl employee :    10% FTE
  • International:
    Yes

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Denmark

Others

Driving License
  • Yes

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