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Pharmacovigilance Support

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Case Processing

Detailed case entry and follow-up Safety narrative writing  Individual Case Safety Reports (ICSRs)  Quality review and medical review

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Literature Monitoring

Literature search for reports of adverse events (AEs)[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=”” css=”.vc_custom_1508216817764{margin-top: 20px !important;}”][vc_column_inner width=”1/2″ css=”.vc_custom_1509188211167{margin-bottom: 20px !important;}”][vc_column_text]

Aggregate Reports

Risk Management REMS
Strategy (REMS) Periodic Safety Update Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Adverse Drug Experience Report (PADER) Development Safety Update Report (PSUR/DSUR)

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Pharmacovigilance Consulting

Signal Detection, Evaluation, and Management
Pharmacovigilance database
SOP and Procedural Document Development Development of PV System Master File (PSMF)or Detailed Description of Pharmacovigilance System (DDPS) Pharmacovigilance trainings[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]