BrightOwl Loader Loading

Summary

·         more than 5 years of diversified experience in Drug Safety, Medical writing, corporate Healthcare, Project Management, and Dentistry with thorough understanding of ich gcp, gvp, new eu-gvp, volume 9a, and cioms guidelines as well as knowledge of 21 cfr parts 11/314/20

·         lean Six Sigma green belt certified professional adept at applying the principles of Six Sigma. active involvement in Project Management related activities including tcs integrated Quality Management System.

·         written, assessed and reviewed pbrers/psurs, dsurs, quarterly safety update reports (qsurs), and Clinical Trial safety progress reports for south africa within tools such as epic and pleasereview.

·         hands on expertise on various Drug Safety Databases such as argus, arisg and sapphire. proficient in MedDRA coding, icd coding, icsr (including medico-legal case) processing and narrative writing.

·         Quality Control of csrs, ib, briefing documents, rtq’s, rmp’s, rems, prac rtq’s, safety assessment reports and clinical overview documents.

·         ambitious, self-motivated individual with Problem Solving abilities and excellent Communication Skills. ability to influence people, proven interpersonal skills and analytical thinking. thorough, structured and strong organisational skills and ability to multi-task

 

 

 

Experiences

Current Experience

  • Business Process Lead

    Mumbai, Maharashtra, India
    Since February 2009

    ·         more than 5 years of diversified experience in Drug Safety, Medical writing, corporate Healthcare, Project Management, and Dentistry with thorough understanding of ich gcp, gvp, new eu-gvp, volume 9a, and cioms guidelines as well as knowledge of 21 cfr parts 11/314/20

    ·         lean Six Sigma green belt certified professional adept at applying the principles of Six Sigma. active involvement in Project Management related activities including tcs integrated Quality Management System.

    ·         written, assessed and reviewed pbrers/psurs, dsurs, quarterly safety update reports (qsurs), and Clinical Trial safety progress reports for south africa within tools such as epic and pleasereview.

    ·         hands on expertise on various Drug Safety Databases such as argus, arisg and sapphire. proficient in MedDRA coding, icd coding, icsr (including medico-legal case) processing and narrative writing.

    ·         Quality Control of csrs, ib, briefing documents, rtq’s, rmp’s, rems, prac rtq’s, safety assessment reports and clinical overview documents.

    ·         ambitious, self-motivated individual with Problem Solving abilities and excellent Communication Skills. ability to influence people, proven interpersonal skills and analytical thinking. thorough, structured and strong organisational skills and ability to multi-task

    ·         More than 5 years of diversified experience in drug safety, medical writing, corporate healthcare, project management, and dentistry with thorough understanding of ICH GCP, GVP, new EU-GVP, Volume 9A, and CIOMS guidelines as well as knowledge of 21 CFR parts 11/314/20

    ·         Lean Six Sigma Green Belt certified professional adept at applying the principles of Six Sigma. Active involvement in Project management related activities including TCS Integrated Quality Management System.

    ·         Written, assessed and reviewed PBRERs/PSURs, DSURs, Quarterly Safety Update Reports (QSURs), and Clinical Trial Safety Progress Reports for South Africa within tools such as EPIC and PleaseReview.

    ·         Hands on expertise on various drug safety databases such as Argus, ArisG and Sapphire. Proficient in MedDRA coding, ICD coding, ICSR (including medico-legal case) processing and narrative writing.

    ·         Quality Control of CSRs, IB, briefing documents, RTQ’s, RMP’s, REMS, PRAC RTQ’s, safety assessment reports and clinical overview documents.

    ·         Ambitious, self-motivated individual with problem solving abilities and excellent communication skills. Ability to influence people, proven interpersonal skills and analytical thinking. Thorough, structured and strong organisational skills and ability to multi-task

Personality

Self Assessment :
ApproachabilityStrategic thinkingSelf-confidenceProactivityProblem solvingOrganizationInterest in knowledgeCreative thinkingFlexibilityEfficiencyDiligenceCuriosityCollaborationAdaptabilityAnalytical thinkingAttention to detailTrust

Knowledge

Self Assessment :
Actions and modes of action of drugs in the human species R&DAnesthesiaAllergy and immunologyCDISCClinical DevelopmentClinical researchClinical Study DesignCMC Clinical trial managementCross-functional team leadershipData AnalysisData entryData ManagementDrug development processDrug regulatory authoritiesDrug Safety and PharmacovigilanceEnglishFDAGCPGood Clinical Practice (GCP)ICH GCP guidelinesICH-GCPInformed Consent ProcessInterpret clinical trial resultsInterpret systematic reviewsIt skillsKnowledge of the drug development processMarketing Authorisation Application (MAA)Marketing approvalMedical writingMicrosoft ExcelMicrosoft OfficeNegotiationNew Drug Application (NDA)Patient Reported Outcome Measures (PROMs)Patient Follow Uppeople managementPharmacovigilancePhases of clinical development (phase I to IV)PowerPointPre-clinical researchPreclinical regulations and practicesPrinciples and ethics of clinical researchProblem-solving methods and troubleshootingProcess improvementProject ManagementRegulatory submissionsSOPSearch literature on clinical trialsStudy outcomes and outcome measuresStrategic PlanningTeam LeadershipTechnical reportsUnderstanding of regulatory guidelinesWriting Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Analyze data Interact with nurses Interact with physicians Interpret dataAdverse event reportingArchive documentationAttend seminarsCapture data on source documentsCoach staffCollaborate with project teamCreates a collaborative team environmentData analysisData codingData entryData validationDevelop ICH/GCP compliant processesDocument adverse eventsDocument data reporting systemsDocument employees training requirementsEnsure data consistencyEnsure good clinical practice (GCP)Extrapolate dataFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesGeneral office managementHandle callsImplement data reporting systemsImplement Quality Management System (QMS)Liaise with doctorsManage projects resourcesManage Quality Management System (QMS) documentationManage subject safetyObserve trends in dataProvide benefit risk assessmentProvide medical insightsProvide trainingQuality control processRead medical literatureRegulatory submissionsReport serious adverse events (SAE)Resolves queriesRespond to audit findingsReview clinical study reportsReview data interpretationReview medical reportsReview quality control activitiesSolve problemsWork under specific instructionsWritten presentation

Education

  • Master in Business Administration (MBA) from Newcastle University Business School in 2012
  • Post Graduate Diploma in Clinical Research in Clinical Research topics from Institute of Clinical Research of India, ICRI in 2008
  • Bachelor in Dentistry from Rajas Dental College and Hospital in 2007

Training and Certification

  • Lean Six Sigma Green Belt in 2014 Certification

Work Preferences

  • Notice Period:
    9 weeks
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Mumbai, Maharashtra, India

Others

Driving License
  • Yes

Similar Candidates

Other Candidates in India

Other Candidates in Mumbai

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like