Safety Data Science Director | Signal & Risk Insights

AbbVie; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie is seeking a safety professional to partner with cross-functional stakeholders in the product safety lifecycle. You will support signal detection, evaluation, and preparation of safety summaries for senior management and regulatory authorities globally.

This role requires deep pharmacovigilance knowledge, ability to work across matrix teams, and mentoring of junior scientists. Location options include multiple AbbVie hubs in the US.

Qualifications

• Knowledge of the drug development process which includes conducting clinical trials, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support.
• Demonstrates ability to connect regulatory obligations and safety science to support safety decision making.
• Understanding of tools, standards and approaches used to efficiently evaluate drug safety is desirable. Serves as a resource to cross-functional colleagues by soliciting input and providing recommendations and conclusions. Demonstrates effectiveness in working in a multidisciplinary, matrix team situation.

Responsibilities

• Perform standard surveillance activities for a product's life cycle by reviewing safety data from trials, safety databases, and literature.
• Collaborate with safety and clinical teams to develop signal assessment strategies and respond to regulatory requests with data-driven analyses.
• Assess impact of safety issues on benefit-risk and communicate findings to inform risk minimization actions and potential labeling changes.
• Prepare and maintain safety sections of Clinical Summary of Safety and related documents, and author global aggregate safety reports per regulatory requirements.
• Lead safety-related activities within PPS and mentor junior safety scientists.
• Demonstrate strong knowledge of pharmacovigilance regulations and cross-functional collaboration.

Skills

Oral and written communication

Microsoft Word & Excel

Project management basics

Independent worker

Education

Bachelor's + 4 years pharmaceutical/safety experience

Master's or PhD + 2 years pharmacovigilance experience

Job description

AbbVie is seeking a safety professional to partner with cross-functional stakeholders in the product safety lifecycle. You will support signal detection, evaluation, and preparation of safety summaries for senior management and regulatory authorities globally.

This role requires deep pharmacovigilance knowledge, ability to work across matrix teams, and mentoring of junior scientists. Location options include multiple AbbVie hubs in the US.