Associate Director, Safety Data Sciences
AbbVie
August 20, 2026
On-site
North Chicago, IL
$141,500 - $268,500 USD yearly
Medical Affairs
Location: Any AbbVie hub location (Lake County, IL; Irvine, CA; South San Francisco, CA; Florham Park, NJ)
Job Summary: Partners with cross-functional stakeholders to support the product safety profile and benefit-risk throughout the product lifecycle via signal detection, signal evaluation, and preparation of written/verbal signal management summaries and risks to patient safety for senior management and global regulatory authorities.
Responsibilities:
- Perform standard surveillance across the product lifecycle by reviewing safety data from clinical trials, safety databases, and the literature.
- Collaborate with safety and clinical teams to develop strategies for signal assessments and regulatory requests; independently analyze multi-source data and lead preparation of ad hoc regulatory safety request materials.
- Use medical judgment to determine safety issue impact on benefit-risk; communicate surveillance findings and safety assessments to inform risk minimization (including label changes).
- Maintain and contribute to safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plan; author/review global aggregate safety reports.
- Prepare key safety data summaries for PST, SRB, senior management, Advisory, and similar meetings.
- Apply pharmacovigilance regulations/guidelines and company SOPs; in-depth knowledge of assigned therapeutic areas; mentor and train safety scientists.
Qualifications:
- Degree in Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
- Bachelors + 4 years clinical/pharma or safety experience; or Masters/doctorate + 2 years.
- Knowledge of drug development process, clinical trials, regulatory submission requirements, product launch, and post-marketing support.
- Understanding of tools/standards/approaches for drug safety evaluation (preferred); strong matrix teamwork and cross-functional resourcefulness.
- Effective oral/written communication; Microsoft Word/Excel; basic project management; able to work independently.
Benefits (if eligible): Paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility.
Job Summary: Partners with cross-functional stakeholders to support the product safety profile and benefit-risk throughout the product lifecycle via signal detection, signal evaluation, and preparation of written/verbal signal management summaries and risks to patient safety for senior management and global regulatory authorities.
Responsibilities:
- Perform standard surveillance across the product lifecycle by reviewing safety data from clinical trials, safety databases, and the literature.
- Collaborate with safety and clinical teams to develop strategies for signal assessments and regulatory requests; independently analyze multi-source data and lead preparation of ad hoc regulatory safety request materials.
- Use medical judgment to determine safety issue impact on benefit-risk; communicate surveillance findings and safety assessments to inform risk minimization (including label changes).
- Maintain and contribute to safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plan; author/review global aggregate safety reports.
- Prepare key safety data summaries for PST, SRB, senior management, Advisory, and similar meetings.
- Apply pharmacovigilance regulations/guidelines and company SOPs; in-depth knowledge of assigned therapeutic areas; mentor and train safety scientists.
Qualifications:
- Degree in Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
- Bachelors + 4 years clinical/pharma or safety experience; or Masters/doctorate + 2 years.
- Knowledge of drug development process, clinical trials, regulatory submission requirements, product launch, and post-marketing support.
- Understanding of tools/standards/approaches for drug safety evaluation (preferred); strong matrix teamwork and cross-functional resourcefulness.
- Effective oral/written communication; Microsoft Word/Excel; basic project management; able to work independently.
Benefits (if eligible): Paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility.