About Me
With 10 years of extensive experience in Pharmacovigilance PV, I have demonstrated proficiency in various facets of the field. This includes the authoring and meticulous quality review of aggregate periodic safety data reports, such as Periodic Benefit Risk Evaluation Reports PBRERs,
Periodic Safety Update Reports PSURs, Periodic Adverse Drug Experience Reports PADERs, and Addendum to Clinical Overviews ACOs. Furthermore, I have cultivated expertise in end to end signal management activities, encompassing signal evaluation reports or Drug Safety Reports DSRs, Health Authority HA requests, Annual data update requests, and Signal validations. My skill set also extends to
crafting and meticulously reviewing patient narratives related to client or sponsor products derived from clinical trials, contributing to the preparation of comprehensive Clinical Study Reports CSRs.
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