Summary

AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.

Job description

Job Description

Supports the planning and execution of the safety strategy for immunology assets during the entire lifecycle of the drug
Leads development and implementation of an asset safety strategy with support of PST-L or management
Supports in the review and synthesis of scientific safety data for critical regulatory and clinical documents — including IB's DSURs, PSURs, RMPs CSRs, etc. - ensuring medical accuracy, scientific rigor, and clarity of content across immunology assets
Facilitates scientific connections and interactions, information exchange across assets within the safety teams
Prepares material on competitive intelligence, current disease state, and standard of care for key indications/disease states
Compiles draft slide presentations for internal and external meetings as required
Interacts with and influences other cross functional departments (e.g. Clinical Development, Statistics, Regulatory Affairs, Clinical Pharmacology, Medical Affairs), as needed, to ensure the successful development, design and implementation of comprehensive safety assessments to support study participants in immunology studies
Drives process improvement and change management for the Immunology Safety team in conjunction with enterprise-wide and functional area plans
Deep dive in literature search and capable to deliver a strong analysis and summary and proposal for any additional needed safety action

Requirements

Scientific or clinical degree (e.g. NP/PA, PharmD, MS, PhD, MPH, including combinations)
At least 5+ years of pharmaceutical industry experience, preferably in patient safety/PV
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols
Strategic thinking and capacity of analyzing aggregate data and conclude
Effectively present recommendations/opinions in group environment both internally and externally
Ability to work effectively under circumstances of uncertainty and complexity
Proven ability to critically evaluate and interpret complex safety data from clinical trials, supporting informed risk-benefit decision-making
Strong ability to influence individual stakeholders and cross-functional teams in a collaborative environment
Must possess excellent oral and written English communication skills
Work collaboratively and lead cross-functional teams
Good communication and influence skills
Good organization and mastering Microsoft Office tools

Benefits

Paid time off
Medical, Dental & Vision
401(k)
Long-term incentive programs

Company overview

AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.