Senior Scientist, Safety Data

Summary

Join AbbVie and partner with cross-functional stakeholders to support the product safety profile and benefit-risk assessment throughout the product lifecycle. You will be responsible for standard surveillance activities, collaborating with safety and clinical teams to develop signal assessment strategies, and analyzing data to support signal assessment and regulatory requests. Your responsibilities include utilizing medical judgment to determine the impact of safety issues, communicating findings to product teams and leadership, and contributing to the preparation and maintenance of safety sections in various documents. You will also support the development and review of global aggregate safety reports and prepare summaries of key safety data for presentations. This role requires proficiency in pharmacovigilance and in-depth understanding of assigned therapeutic areas. The position can be remote in the US.

Requirements

• Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing); Bachelors + 2 years clinical/pharma or safety work experience
• Masters or doctorate, 1-2 years clinical/pharma or safety work experience (e.g. MPH, PharmD, PhD, or Masters in a Health Science)
• 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
• Familiar with working in a multidisciplinary, matrix team situation
• Effective oral and written communication skills with the ability to manage multiple projects simultaneously
• Microsoft WORD and EXCEL skills and Basic Project Management skills
• Able to work independently with guidance from manager

Responsibilities

• Responsible for standard surveillance activities for a product’s life cycle (one or more assigned compounds and products) through review of safety data from clinical trials, safety databases, and the literature
• Collaborates with safety and clinical teams to develop strategies and approaches for signal assessments and regulatory requests by analyzing data from multiple sources
• Analyzes data to support signal assessment and contributes to ad hoc regulatory safety requests using data from multiple sources with supervision
• Utilizes medical judgment to determine the impact of identified safety issues on the compound/ product’s benefit-risk profile
• Communicates findings of surveillance activities and safety assessments to product teams and leadership to inform on necessary risk minimization activities, including label changes
• Collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets and Risk Management Plan
• Support strategy development, authorship and review of global aggregate safety reports in accordance with regulatory requirements and standard operating procedures with supervision
• Prepares summaries of key safety data for PST, SRB, senior management, Advisory and other similar meetings with supervision
• Proficient in pharmacovigilance regulations, guidelines, and company standard operating procedures
• In depth understanding of compounds within assigned therapeutic areas, including safety profile and where applicable, labeling, literature, clinical and regulatory issues

Preferred Qualifications

Understanding of tools, standards and approaches used to efficiently evaluate drug safety is desirable, not required

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs