Pharmacovigilance (Drug Safety)
Scientific and operational pharmacovigilance covering the full ICSR lifecycle (collection, triage, coding, regulatory submission), signal detection, aggregate safety reporting, benefit-risk evaluation, and PV system oversight. Distinct from Regulatory Affairs (product registration/labeling submissions) and Clinical Operations (trial conduct); focus here is on post-marketing and clinical safety surveillance under GVP/ICH-GCP.
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Individual contributor
Scientific and operational pharmacovigilance covering the full ICSR lifecycle (collection, triage, coding, regulatory submission), signal detection, aggregate safety reporting, benefit-risk evaluation, and PV system oversight. Distinct from Regulatory Affairs (product registration/labeling submissions) and Clinical Operations (trial conduct); focus here is on post-marketing and clinical safety surveillance under GVP/ICH-GCP.
Scientific and operational pharmacovigilance covering the full ICSR lifecycle (collection, triage, coding, regulatory submission), signal detection, aggregate safety reporting, benefit-risk evaluation, and PV system oversight. Distinct from Regulatory Affairs (product registration/labeling submissions) and Clinical Operations (trial conduct); focus here is on post-marketing and clinical safety surveillance under GVP/ICH-GCP.
Scientific and operational pharmacovigilance covering the full ICSR lifecycle (collection, triage, coding, regulatory submission), signal detection, aggregate safety reporting, benefit-risk evaluation, and PV system oversight. Distinct from Regulatory Affairs (product registration/labeling submissions) and Clinical Operations (trial conduct); focus here is on post-marketing and clinical safety surveillance under GVP/ICH-GCP.
Scientific and operational pharmacovigilance covering the full ICSR lifecycle (collection, triage, coding, regulatory submission), signal detection, aggregate safety reporting, benefit-risk evaluation, and PV system oversight. Distinct from Regulatory Affairs (product registration/labeling submissions) and Clinical Operations (trial conduct); focus here is on post-marketing and clinical safety surveillance under GVP/ICH-GCP.
Scientific and operational pharmacovigilance covering the full ICSR lifecycle (collection, triage, coding, regulatory submission), signal detection, aggregate safety reporting, benefit-risk evaluation, and PV system oversight. Distinct from Regulatory Affairs (product registration/labeling submissions) and Clinical Operations (trial conduct); focus here is on post-marketing and clinical safety surveillance under GVP/ICH-GCP.
Scientific and operational pharmacovigilance covering the full ICSR lifecycle (collection, triage, coding, regulatory submission), signal detection, aggregate safety reporting, benefit-risk evaluation, and PV system oversight. Distinct from Regulatory Affairs (product registration/labeling submissions) and Clinical Operations (trial conduct); focus here is on post-marketing and clinical safety surveillance under GVP/ICH-GCP.