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Nargis Jahan
About
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HR Director I People-First Leader I Driving Retention I DEI and Organizational Health
Miami, Florida, United States
Résumé
Jobs
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Human Resources DirectorImpulseIQ ConsultingAug 2024 - Current (2 years 1 month)- FHuman Resources ManagerFigno Blissbery InternationalJul 2020 - Jul 2024 (4 years 1 month)
- Senior Pharmacovigilance AssociateApcer Life sciencesNov 2012 - Feb 2015 (2 years 4 months)• Responsible for quality check and managing, Individual Case Safety Reports (ICSRs), both solicited and unsolicited in ARISg. • Responsible for case triage (adverse events, seriousness criteria’s, expectedness/labeling). • Narrative writing/Safety writing. • Case processing (MedDRA coding, labeling/Listedness of events) of all types of reports like spontaneous reports, literature reports, ASPR’s reports (Anonymized single patient reports) or Health Authoriry reports, Composite reports and clinical study reports in ARISg for US and EU clients. • Coding of suspect and concomitant medications as per CDD, WHO Drug dictionary and coding of events through MedDRA (version 16.0) in ARISg. • Evaluation of Listedness/Labeledness of events via SmPC a
- Senior Pharmacovigilance Quality AnalystWiproJun 2009 - Oct 2012 (3 years 5 months)• Responsible for doing the complete quality check, managing and processing the Individual Case Safety Reports (ICSRs) in Argus. • Narrative writing/Safety writing. • Categorizing events on the basis of seriousness criteria as an important medical event (IME), life threatening or leading to some kind of disability and finally deciding that whether the case will be serious or non-serious as per the pharmacovigilance guidelines. • Analyzing the suspect products as per the scenario of the case and as per the pharmacovigilance guidelines. • Analyzing whether the case would be initial or follow up on the basis of information available in Global Safety Data Base for Pharmacovigilance (ARGUS). • Coding of suspects and concomitant medications as pe
Education
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- Master of Science - MS, Clinical Research and RegulatorySikkim Manipal Institute of Technology SMU
- Bachelor of Pharmacy - BPharmJamia Hamdard