Associate Director, Safety Data Sciences
AbbVie
August 20, 2026
On-site
Florham Park, NJ
$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).
Responsibilities:
- Support product safety profile/benefit-risk across lifecycle via signal detection, signal evaluation, and preparation of written/verbal signal management summaries for senior management and global regulatory authorities.
- Conduct standard surveillance by reviewing safety data from clinical trials, safety databases, and literature for assigned compounds/products.
- Collaborate with safety and clinical teams to develop signal assessment/regulatory request strategies; independently analyze data and lead ad hoc regulatory safety request materials using multiple data sources.
- Use medical judgment to assess impact on benefit-risk; communicate findings to product teams/leadership to support risk minimization actions (including label changes).
- Maintain/author safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plan; author/review global aggregate safety reports per regulations/SOPs.
- Prepare safety data summaries for PST, SRB, senior management, Advisory, and similar meetings; lead internal safety-related initiatives.
- Apply pharmacovigilance regulations/guidelines/SOPs; maintain in-depth knowledge of assigned therapeutic area compounds; mentor/train new safety scientists.
Qualifications:
- Degree in Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
- BS + 4 years clinical/pharma or safety experience; or MS/Doctorate + 2 years (e.g., MPH, PharmD, PhD, or MS in Health Science).
- Knowledge of drug development process and ability to connect regulatory obligations to safety decision-making.
- Desirable: tools/standards/approaches to evaluate drug safety; resource to cross-functional colleagues; effective in multidisciplinary matrix teams.
- Strong oral/written communication; Microsoft Word/Excel and basic project management; able to work independently with minimal supervision.
Benefits (if eligible): Paid time off; medical/dental/vision insurance; 401(k). Eligible for long-term incentive programs.
Responsibilities:
- Support product safety profile/benefit-risk across lifecycle via signal detection, signal evaluation, and preparation of written/verbal signal management summaries for senior management and global regulatory authorities.
- Conduct standard surveillance by reviewing safety data from clinical trials, safety databases, and literature for assigned compounds/products.
- Collaborate with safety and clinical teams to develop signal assessment/regulatory request strategies; independently analyze data and lead ad hoc regulatory safety request materials using multiple data sources.
- Use medical judgment to assess impact on benefit-risk; communicate findings to product teams/leadership to support risk minimization actions (including label changes).
- Maintain/author safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plan; author/review global aggregate safety reports per regulations/SOPs.
- Prepare safety data summaries for PST, SRB, senior management, Advisory, and similar meetings; lead internal safety-related initiatives.
- Apply pharmacovigilance regulations/guidelines/SOPs; maintain in-depth knowledge of assigned therapeutic area compounds; mentor/train new safety scientists.
Qualifications:
- Degree in Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
- BS + 4 years clinical/pharma or safety experience; or MS/Doctorate + 2 years (e.g., MPH, PharmD, PhD, or MS in Health Science).
- Knowledge of drug development process and ability to connect regulatory obligations to safety decision-making.
- Desirable: tools/standards/approaches to evaluate drug safety; resource to cross-functional colleagues; effective in multidisciplinary matrix teams.
- Strong oral/written communication; Microsoft Word/Excel and basic project management; able to work independently with minimal supervision.
Benefits (if eligible): Paid time off; medical/dental/vision insurance; 401(k). Eligible for long-term incentive programs.