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… Show more 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… Show more 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… Show more 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… Show more 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

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