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Summary

An experienced and talented person in the field of pharmacovigilance who has grown from the grassroots of being a drug safety associate to the present level. I possess in depth knowledge of pharmacovigilance from single case processing, aggregate reporting, medical writing and lietrature review to business development, team leadership and client relationship management. I also possess excellent communication skills and aim to build and nurture long term relationships with clients. Having worked with established multinationals and start up companies, flexibility and organized work are my key strengths. Having proven people management skills, I am comfortable working with people at all levels and have the ability to manage performance and motivate staff on an individual and a team level. I aim to work closely with clients from all geographical regions and also aim to work towards comprehensive and robust pharmacovigilance solutions

Experiences

Current Experience

  • Consultant- Pharmacovigilance, medical writing, business development, content writing, training
    Since May 2016

  • Vice President- Pharmacovigilance
    Since February 2014

Past Experience

  • Pharmacovigilance consultant
    March 2013 --- February 2014

  • Drug Safety Physician-TL
    August 2011 --- March 2013

  • Senior Drug Safety Associate/Subject Matter Expert
    September 2008 --- August 2011

  • Project Trainee
    April 2008 --- September 2008
    A comparative study of the vaccine safety regulations in the FDA, EMEA and the TGA conducted as a part of my curriculum

  • Trainee Clinical Research Co-ordinator
    September 2007 --- March 2008
    As a part of curriculum

Personality

Self Assessment :
ApproachabilityAdaptabilityAnalytical thinkingAssertivenessAttention to detailAuthenticityCommunicativeCollaborationCharmAggressivenessCritical thinkingCreative thinkingEfficiencyOptimismOrganizationSelf-disciplineTrustService oriented

Knowledge

LinkedIn Assessment :
PharmacovigilanceClinical researchMedical writingMedDRAICH-GCPClinical trialsDrug SafetyGCPPharmaceutical IndustryFDASOPClinical Data ManagementCROInformRegulatory affairsOracle ClinicalCTMS21 CFR Part 11Team LeadershipEDConcologyClinical DevelopmentRegulatory submissionsVaccinesData ManagementClinical monitoringTeam BuildingLiterature Reviewsaggregate reportingBusiness DevelopmentManage Client RelationshipsSignal DetectionRisk ManagementCRMSOPProject ManagementStandard Operating Procedure (SOP)Customer Relationship Management (CRM)Good Clinical Practice (GCP)

Skills and Expertise

Self Assessment :
Create SOPs Analytical skills Develop clinical trial protocols Search literature on clinical trials Write protocolsAchieve sales objectivesAct as the main line of communication between the sponsor and the investigator Write papersAdvise on medical perspectivesAdverse event reportingAdvise on strategyAnalyze data/information to determine potential relationships.Analyse growth / improvement potentialAssess adverse reactionsAssess business and scientific ethicsAssess quality process issuesassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Attend seminars, courses and meetings within and outside the companyConduct literature searchesCoordinate projectsCreate SOPs

Education

  • Master of Business Administration (MBA) in Total quality management and project management from Sikkim Manipal University of Health, Medical and Technological Sciences in 2014
  • in from Rajiv Gandhi University of Health Sciences in 0
  • M.Sc and PGDPM at ICRI, Bangalore Campus in Clinical Research and pharmaceutical management from Cranfield University in 0

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Hindi
Full Proficiency
French
Elementary Proficiency

Work Preferences

  • Notice Period:
    2 weeks
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    70% FTE
    BrightOwl freelancer :    38 Hours per week :    40 Free Per Month(in coming months)
    BrightOwl employee :    70% FTE
  • International:
    Yes

Area / Region

Bengaluru, Karnataka, India

Others

Driving License
  • No