Associate Director, Safety Data Sciences

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 to support the product safety profile and benefit-risk assessment throughout the product lifecycle. Responsibilities include signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety for senior management and global regulatory authorities.

Responsibilities

• Perform 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.
• Collaborate with safety and clinical teams to develop strategies and approaches for signal assessments and regulatory requests by analyzing data from multiple sources.
• Independently analyze data for signal assessment and lead preparation of materials for ad hoc regulatory safety requests using data from multiple sources.
• Utilize medical judgment to determine the impact of safety issues on the product’s benefit-risk profile.
• Communicate findings of surveillance activities and safety assessments to product teams and leadership to inform risk minimization activities, including label changes.
• Collaboratively prepare and maintain safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plans.
• Independently author, strategize, and review global aggregate safety reports in accordance with regulatory requirements and standard operating procedures.
• Prepare summaries of key safety data for PST, SRB, senior management, Advisory, and other similar meetings.
• Partner to lead safety-related activities and initiatives internal to PPS.
• Maintain proficiency in pharmacovigilance regulations, guidelines, and company standard operating procedures.
• Develop an in-depth understanding of compounds within assigned therapeutic areas, including safety profile, labeling, literature, clinical, and regulatory issues.
• Mentor and train new safety scientists.

Qualifications

• Degree in Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
• Bachelor’s degree + 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, operations management, regulatory requirements for submission, product launch, and post-marketing support.
• 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.
• Effectiveness in working in a multidisciplinary, matrix team environment.
• Strong oral and written communication skills with the ability to manage multiple projects simultaneously.
• Proficiency in Microsoft Word and Excel, 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.