Associate Director, Safety Data Architect (Remote)

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

Purpose:

This position reports Safety Data Architect, Director, 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 architect is a strategic partner to the Product Safety Team Lead physician and the Product Safety Team Therapeutic Area physician. The safety data architect is responsible for summarizing any potential safety concerns observed at the product level from clinical trial data. The safety data architect drives consistency across clinical trial protocols through contribution to the safety management plan.

Responsibilities:

• Functions as a driver for data in aggregate to enhance presentation of, or delivery of compound safety within PPS and Clinical Teams.
• Instrumental 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 PST Lead and PST TA physician, identifying potential safety concerns from clinical trial data.
• Ensures consistent safety perspective in study protocols, annual reports, and acts as a key driver of updates to Investigator Brochures, Safety Monitoring Plans, and other ad hoc safety reports, as applicable.
• Reviews for consistency across an assigned compound(s) and indication(s) for safety risk language, AESIs (adverse events of special interest), frequency of data in aggregate review, through contributions to the safety monitoring plan.
• In partnership with PST Lead, PST TA physici