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Regulatory Manager Resume Sample, Experience : 8 years

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Biodata

Name of the Candidate:[Private]
Name of the Post Applied:Regulatory Manager
Job related skills / software:Vigiflow, Aggregate Reports, Packaging Labels, Regulatory Document Review
Category:Miscellaneous
Sub Category:Miscellaneous
Years of Experience:8 years
State:Uttar Pradesh
Gender:Female
Salary Expected per Month(Rs):80,000 to 90,000
Highest Qualification attained:M.Pharm
Major / Specialization:Pharmacology
Email Id:[Private]
 
Are you looking for job now?:Yes
Can the recruiter contact you?:Yes
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Resume Format / CV Sample Template / Example / Model :

    

 

 

WORKEXPERIENCE

CentralDrugsStandard ControlOrganization,FDABhawan,NewDelhi              Oct-19-CurrentPharmacovigilance-TechnicalDataAssociate,Pharmacovigilance-PSUR Division

  • WebsiteUpdatingRelated to PSUR Division
  • Periodic Safety Update (PSUR)review, Risk Management Plan (RMP) review, Prescribing Information (PI) Review.
  • Pre-Screening&reviewofapplicationrelatedtoPharmacovigilancedivisionwhenever necessary.
  • MaintainingdocumentsandrequirementsaspertherequirementofISO.

 

PharmacovigilanceProgrammeofIndia,IndianPharmacopoeiaCommission,Ghaziabad

PatientSafetyPharmacovigilanceAssociate (TeamLead,Training&Education Division)       Oct’16- Oct2019

  • ProcessingofICSRs(VigiFlowsoftware)
  • Coding ofadversereactionswiththehelp ofMedDRA.
  • GeneratingfollowupqueriesandsendingFollow-uprequests.
  • QualityreviewofICSRsinSafetydatabaseandgradingofICSRs.
  • Coordinatingwithsignaldetectionteamforsignalreviewor strengtheningincaseofunknown/unlistedICSRsis reported.
  • Involved as a team lead of training & education division in organizing skill development, inductioncumtrainingandotherawareness programmeforthestakeholders.
  • Coordinatingwithregionaltrainingcenters forconductingregionaladvancelevelworkshop.
  • Developing/updatingmodulesofallleveloftrainingprogrammes.
  • Regularfollowupwiththetrainingparticipants formonitoringorreviewingtheiractionplan.
  • Assisting in preparation & publication of training report of the previous year & preparation oftrainingschedulefortheupcomingyears.
  • Preparing/updatingrelatedSOPs.
  • Conductanceofcoretraining panelmeeting.
  • ProvidehandsontrainingonVigiFlowSoftwaretostakeholders.

Pharmacovigilance Programme of India, (AMC: Sarojni Naidu Medical College, Agra)PharmacovigilanceAssociate                                                                                          Sep’15-Oct’16

  • CollectionofADRReportsfromdifferentwardsofADRMonitoringcenter.
  • CaseProcessingandDataentryinVigiFlowandNikshay.
  • Follow up with the reporter/patient for Completeness of Individual Case Safety Reports as perSOPs.
  • CommunicationandCoordinationwithPublicHealthProgrammes(PHPs)likeRNTCP&NACO.
  • Training/SensitizationtothehealthcareprofessionalonPharmacovigilance.
  • CoordinationwithDIOforAEFIreports.

 

TeerthankarMahaveerUniversity,Moradabad,UttarPradesh

AssistantProfessor(Pharmacology)                                                                                Aug’14–Aug’15

  • Supervisedandsupportedteaching assistants.
  • Culturalcoordinatoroftheinstitutetopromotecultural/co-curricularactivities atUniversityLevel
  • Developedprofessionallogisticstoimprovisestudentperformance.
  • Guided,leadand mentoredstudentsinresearchprojects.
  • Evaluated,monitoredandmentoredstudent’sacademicprogress.

 

ShivdanSinghInstituteofTechnology&Management, Aligarh

AssistantProfessor                                                                                                           Feb 2014-July2014

  • Evaluated,monitoredandmentoredstudent’sacademicprogress.
  • Supervisedandsupportedteachingassistants.
  • Serveand support functionalactivitiesofdepartmentalcommittees.
  • Assess, review and evaluate student activities and progress.


    Assist and support senior professors in ttheir day to day tasksandfunctions.

 

EDUCATION

BachelorofPharmacy (B.Pharm)                                                                                                  2007-2011

InstituteofPharmacy,H.C.P.G.College,Varanasi

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