Manager, Safety Data Architect

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

This position is part of Safety Data Architect team in Clinical Trial Patient Safety. The PPS organization works collaboratively and strategically with colleagues across the product clinical lifecycle to identify, evaluate, understand and communicate the safety profile of AbbVie drugs to protect patients worldwide. The safety data lead provides strategic and tactical support to the Safety Data Architect and Product Safety Team Lead physician and the Product Safety Team Therapeutic Area physician. The safety data lead is responsible for assisting in summarizing any potential safety concerns observed at the product level from clinical trial data. The safety data lead assists in deliverables for the safety data architect team and independently supports later stage products.

Responsibilities:

•Independently supports later stage products with minimal number of clinical trials or one indication on large, late-stage products.  Presents compound safety data for later stage products with minimal number of clinical trials or a therapeutic indication of large, late-stage products within PPS and Clinical Teams or in support of an SDA.
•Assists the safety data architect in coordination of deliverables and meetings to review data in aggregate with the PST Leads and PST TA physicians. Proactively utilizes clinical experience and medical knowledge to support the review of potential safety concerns from clinical trial data. In partnership with the safety data architect supports contribution of clinical trial data to regulatory response.
•A strong communicator, ensures alignment, consistency, and data integrity for assigned safety activities.  Proactively promotes best practice and knowledge sharing when communicating clinical