Senior Product Manager, Safety Operations (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 into the Safety Operations Product Leadership team which is part of the International Strategy & Safety Operations (ISSO) function in Patient Safety. The Patient Safety organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand, and communicate the safety profile of our drugs to protect patients worldwide. ISSO oversees the intake, processing, and reporting of patient safety information.

Responsibilities:

With oversight of the Oncology Portfolio Lead, the Sr. Product Manager oversees the accuracy, completeness and timeliness of all Safety Operations scientific activities and deliverables for Oncology and/or focused disease state. These activities/deliverables include support and input into the lifecycle of the asset (from pre-clinical, clinical trial and post- marketing deliverables), submissions and product launches, studies, scientific collaborations, etc.

With oversight of the Portfolio Lead, responsibilities include:

• The Sr. Product Manager is the point of contact for Product Safety Teams, QPPV and PPS Leadership contextualization of Adverse Event data (from an ICSR perspective) for focused therapeutic product and/or disease state for global regulatory responses, audits/inspections, proactive safety communications, etc.
• Collaborates with Data Management or Business Technology to extract required data and reports.
• Supports and provides guidance to the Safety Operations Product Managers to prepare communication materials that contextualize the data in a meaningful way in order to facilitate high-quality safety responses and narratives.
• Partners