Director, Safety Data Sciences - Lead Global Safety Signals

BioSpace; North Chicago (IL); On-site; USD 240,000 - 320,000; Full time

Job summary

AbbVie is seeking a safety leadership professional to partner with cross functional stakeholders in monitoring product safety across the lifecycle. You will drive signal detection, evaluation, and risk communication to senior management and regulators globally.

You will lead a team of safety data scientists, mentor colleagues, and prepare key safety documents while ensuring compliance with global regulations. Strong communication and strategic planning are essential.

Qualifications

• Degree in Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
• Bachelors + 7 years pharma or safety experience or Masters/PhD + 5 years.
• Knowledge of drug development, regulatory requirements, and safety reporting.
• Ability to connect regulatory obligations to safety decisions.
• Experience influencing senior management and cross-functional partners.
• Familiarity with safety data analyses and standard operating procedures.
• Strong written and oral communication, multi-project management.
• Experience with team mentoring and resource optimization.

Responsibilities

• Oversee surveillance and regulatory activities in a Therapeutic Area.
• Lead a Safety Data Sciences team within the Product Safety Team.
• Provide oversight of both FTEs and contract personnel.
• Collaborate with Therapeutic Area heads and physicians to shape safety strategies.
• Author and review global aggregate safety reports per regulatory standards.
• Assess impact of safety issues on benefit-risk profile using medical judgment.
• Prepare safety sections for CSRs, Investigator's Brochures, and risk plans.
• Ensure deliverables align with company standards and regulations.
• Lead safety initiatives with internal and external partners.
• Prepare concise safety summaries for leadership and committees.
• Mentor new safety scientists and develop colleagues.

Skills

Drug safety

Regulatory knowledge

Communication skills

Leadership

Stakeholder collaboration

Problem solving

Independent work

Mentoring

Strategic planning

Data analysis

Team resource management

Clinical trial familiarity

Regulatory submissions

Documentation writing

Communication with senior management

Education

Health sciences degree

Bachelor’s degree with 7+ years pharma/safety experience

Master’s or Doctorate in Health Science

Tools

Microsoft Word

Microsoft Excel

Basic Project Management

Job description

AbbVie is seeking a safety leadership professional to partner with cross functional stakeholders in monitoring product safety across the lifecycle. You will drive signal detection, evaluation, and risk communication to senior management and regulators globally.

You will lead a team of safety data scientists, mentor colleagues, and prepare key safety documents while ensuring compliance with global regulations. Strong communication and strategic planning are essential.