Sr Medical Director, Medical Safety Evaluation, Immunology

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

Serve as Indication Product Safety Lead for one or more products under the direction of Group Medical Director Medical Safety Evaluation. Supporting assigned product with safety expertise through its lifecycle (including during the time of clinical development, marketing registration and post marketing), Interpreting, summarizing and presenting safety data in compliance with the regulatory guidelines.

Responsibilities:

•Understanding and application of pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance

•Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products

•Leading, setting the strategy and, when appropriate, authoring the key documents with safety data, including but not limited to, medical safety assessments, parts of submission dossier and regulatory responses.

•Applying current regulatory guidance as appropriate for safety surveillance

•Analyzing, interpreting, and summarizing aggregate safety data and communicating these analysis and interpretation to cross-functional teams and senior management

•Independently writing, reviewing, and providing input on technical documents

•Providing oversight, leading the strategy as well as authoring when applicable, the key sections for periodic reports (e.g. PSURs, DSURs, PADERs and Safety sections of the IBs)

•Leading and setting the strategy, in collaboration with the development medical lead of study protocols and informed consents

•Defining and implementing risk management strategies for assigned product/indication

•Proactively engaging, inspiring, coaching and mentoring team members and colleagues

•Co-authoring public