
Sachin Arora
PCRF Designer

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Skills
Clinical data managementPharmacovigilanceClinical trialsIch gcpPharmacologyGcpPharmaceutical industryEdcClinical developmentMedical writingResource managementOracle clinicalRegulatory affairsCtmsSopClinical pharmacologyMicrosoft officeDrug discoveryRegulatory requirementsClinical monitoringPharmaceuticsDrug safetyManagement presentationsExcelRegulatory submissions21 cfr part 11Quality assuranceManaging processesFluent englishMeddraMicrosoft excelProject managementEnglishGood clinical practiceStandard operating procedureClinical study designClinical researchTeachingAnimal modelsLifesciencesWestern blottingMolecular biologyQualitative researchElisaAbout me
Having experience on Java and J2EE technologies along with hands on experience on Tibco BW. Domain:Banking & Finance
Education

Poona College of Pharmacy
-M Pharm Pharmacology
Guru Gobind Singh Indraprastha University
-B Pharm Pharmacy
Experience

Novartis Healthcare
Jan 2006 - Jan 2007PCRF Designer
Indegene
Jan 2006 - Jan 2006Assistant Editor
Novartis
Dec 2006 - Mar 2010Data ManagerClinical Data Management for Phase I, II, III and IV trials across all therapeutic areas including Oncology.

INC Research
Apr 2010 - Oct 2010CDAComplete bouqet of Clinical Data Management Activities

Kinapse
Oct 2010 - May 2013Project ManagementPeople ManagementQuality Assurance for PV divisionSME for ICSR Domain Project Management within Pharmacovigilance service line
PV Consultant
Jul 2012 - May 2013Senior Safety Analyst
Oct 2010 - Jul 2012

Sciformix
May 2013 - Jul 2015Managing a team size of 90 team members (Direct+ Indirect) for a pharmacovigilance related project.
Senior Project Manager
Jan 2015 - Jul 2015Project Manager
May 2013 - Dec 2014

Tata Consultancy Services
Jul 2015 - Jun 2018Delivery Manager
Labcorp
Jun 2018 - May 2021Delivery Manager
Fortrea
May 2021 - nowAssociate Director
Licenses & Certifications

Design and interpretation of clinical trials
CourseraApr 2014
Vital signs: understanding what the body is telling us
CourseraJun 2014
Languages
- enEnglish
- hiHindi
- maMarathi
- puPunjabi
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