To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, expectedness, and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events. This includes completion of all required supporting documentation such as trackers.
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This role supports the NQPPV Network Lead to fulfil the legal requirements to ensure oversight of AbbVie’s PV system and ensures that National QPPVs (NQPPVs) meet their legal obligations worldwide. The role is the linchpin to a strong & experienced NQPPV Network. Key responsibilities include acting as the primary point of contact for all European NQPPVs.
The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements in the United States. This dual-role position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder in maintaining product compliance.
Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for client marketed products and clinical trials. Completion of the case management lifecycle including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up and submissions. Perform case processing and data gathering tasks within Argus Safety Database and other client systems. Assist with business partner and other query management.