Sahil Matharoo

Experience

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  Ch. Devi Lal College of Pharmacy

  Aug 2012 - Aug 2016

  Assistant Professor of Chemistry

  TeachingAcademic Documentation

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  Baddi University of Emerging Sciences and Technology, Budha (Makhnumajra), Solan

  Sept 2016 - Jul 2017

  Assistant Professor

  Teaching DocumentationRegulatory Submissions

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  PAREXEL International (India) Private Ltd

  Aug 2017 - now

  More than five years of experience in Pharmacovigilance including triage, data entry and data validation.Trained in managing Individual Case Safety Reports (ICSRs) of various case types (spontaneous, Clinicalstudies and retrospective programs). Familiar with international drug safety regulations (includingInternational Council for Harmonization (ICH) guidelines on safety and efficacy, US Food and DrugAdministration guidelines (FDA) guidelines, Council for International Organizations of Medical Sciences(CIOMS), New European Union Pharmacovigilance legislation. Almost five-year experience in teaching. Trainedand mentored PV scientists in various activities of case processing Show less More than five years of experience in Pharmacovigilance including triage, data entry and data validation.Trained in managing Individual Case Safety Reports (ICSRs) of various case types (spontaneous, Clinicalstudies and retrospective programs). Familiar with international drug safety regulations (includingInternational Council for Harmonization (ICH) guidelines on safety and efficacy, US Food and DrugAdministration guidelines (FDA) guidelines, Council for International Organizations of Medical Sciences(CIOMS), New European Union Pharmacovigilance legislation. Almost five-year experience in teaching. Trainedand mentored PV scientists in various activities of case processing Show less More than four year of experience in Pharmacovigilance including triage, data entry and data validation.Trained in managing Individual Case Safety Reports (ICSRs) of various case types (spontaneous, Clinicalstudies and retrospective programs). Familiar with international drug safety regulations (includingInternational Council for Harmonization (ICH) guidelines on safety and efficacy, US Food and DrugAdministration guidelines (FDA) guidelines, Council for International Organizations of Medical Sciences(CIOMS), New European Union Pharmacovigilance legislation. Show less Experienced in the management of Individual Case Safety Reports (ICSRs) of all case types(spontaneous, clinical studies and solicited programs) which includes:-Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelineswithin which they need to be submitted to the regulatory authorities-Registration of ICSRs into the safety database-Conducting duplicate searches prior to registration and identifying potential duplicates and managingduplicate cases appropriately-Data entry of ICSRs in the safety database, including determining the expectedness of adverse eventsagainst various labeling documents (such as summary of product characteristics, Core Data Sheet,Investigator's Brochure etc.) writing case summaries, assessing causalities if required and writingcompany comment if required-Data validation i.e. cross checking against source documentation-Experienced in MedDRA coding in accordance with “MedDRA term selection: Points to consider”-Maintaining a good working knowledge of the Adverse Event safety profile of assigned drugs,Reference Safety Information documents, data entry conventions and guidelines, client procedures andinternational drug safety regulations including: Awareness of global regulatory reporting obligations and organizing workload to ensure compliancewith internal and regulatory timelines for adverse event reporting Experienced in handling the ERP (Enterprise Resource Planning) Global Submissions to European Medicines Agency Health Authority (Final Regulatory Assessmentand Completion and case distribution of submission activity), CIOMS submissions and E2Bsubmissions to Local Health Authorities Show less

  • Drug Safety Specialist

    Apr 2022 - now

  • Drug Safety Associate-II

    Jun 2020 - Mar 2022

  • Pharmacovigilance Analyst

    Oct 2018 - Jun 2020

  • Pharmacovigilance Scientist

    Aug 2017 - Oct 2018