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pharmacovigilance & case processing ICSR

$10/hr Starting at $25

Considerable drug safety knowledge and experience in pharmacovigilance/drug safety profile. More than 9 years of experience in Pharmacovigilance (PV) with expertise in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies, solicited programs and literature articles) which include triage, registration, duplicate search, data entry, Medical Dictionary for Regulatory Activities (MedDRA) coding, data validation, quality review and quality checks of ICSRs. Had worked with international clients and experienced in organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting. Trained and mentored PV scientists in various activities of case processing. Managing training for the new recruits and conducting refresher trainings for the PV staff. Worked on ARGUS, AWARE and AEGIS databases.

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$10/hr Ongoing

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Considerable drug safety knowledge and experience in pharmacovigilance/drug safety profile. More than 9 years of experience in Pharmacovigilance (PV) with expertise in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies, solicited programs and literature articles) which include triage, registration, duplicate search, data entry, Medical Dictionary for Regulatory Activities (MedDRA) coding, data validation, quality review and quality checks of ICSRs. Had worked with international clients and experienced in organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting. Trained and mentored PV scientists in various activities of case processing. Managing training for the new recruits and conducting refresher trainings for the PV staff. Worked on ARGUS, AWARE and AEGIS databases.

Skills & Expertise

Data ValidationMedical DeviceNarrativePharmacovigilanceQuality Control

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