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Summary

A dedicated and self motivated pharmacy professional with qualified experience for more than four years in preparing and reviewing Clinical Study Reports (CSR) and other supporting documents & coordination with cross functional teams for timely regulatory submissions of studies. Proficient in developing protocols, informed consent forms, case report forms for clinical studies as per compliance with appropriate local regulatory requirements, ICH-GCP guidelines, Standard Operating Procedures (SOPs), and sponsor requirements. Registered Pharmacist with Delhi Pharmacy Council (India).

Experiences

Current Experience

  • SOPs and Process Governance Expert / Document Management Expert
    Since March 2015

Past Experience

  • SOPs and Process Governance Expert
    January 2015 --- March 2015

  • R&D Scientist
    June 2012 --- July 2014

  • Research associate
    June 2010 --- May 2012

Knowledge

LinkedIn Assessment :
Medical writingICH-E3ICH-GCPSOPClinical researchProtocolRegulatory submissionsPharmacovigilancePharmaceutical IndustrypharmacologyPharmacokineticsCRF designClinical trialsDrug DevelopmentLife SciencesPharmaceuticsDocument ManagementeTMF

Education

  • Master of Pharmacy in Pharmacology from National Institute of Medical Sciences in 2010
  • Bachelor of Pharmacy (B.Pharm.) in from JCD College of Pharmacy, Kurukshetra University in 2007
  • Diploma in Pharmacy in from DIPSAR (Delhi Institute of Pharmaceutical Sciences and Research), Delhi University in 2004

Area / Region

Amsterdam, Netherlands

Others

Driving License
  • No