Associate Director, Safety Data Sciences

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 including immunology, oncology and neuroscience—and products and services in our Allergan Aesthetics portfolio.

This position can be based at any AbbVie hub location including: Lake County, IL; Irvine, CA; South San Francisco, CA; or Florham Park, NJ.

About the role

This position partners with cross-functional stakeholders in support of the product safety profile and benefit-risk throughout the product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety to present to senior management and regulatory authorities globally.

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.
• Independently analyzes data for signal assessment and leads preparation of materials for ad hoc regulatory safety requests using data from multiple sources.
• Utilizes medical judgment to determine the impact of the safety issue on the 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.
• Independently authors, strategizes, and reviews global aggregate safety reports in accordance with regulatory requirements and standard operating procedures.
• Independently prepares summaries of key safety data for PST, SRB, senior management, Advisory, and other similar meetings.
• Partners to lead safety-related activities/initiatives internal to PPS.
• 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.
• Mentors and trains new safety scientists.

Qualifications

• Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
• Bachelor’s + 4 years of clinical/pharma or safety work experience, or Master’s or doctorate + 2 years of clinical/pharma or safety work experience (e.g., MPH, PharmD, PhD, or Master’s in a Health Science).
• Knowledge of the drug development process, including 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.
• 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 minimal direct supervision.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.