Associate Director, Safety Data Sciences
AbbVie
August 20, 2026
On-site
South San Francisco, CA
$141,500 - $268,500 USD yearly
Medical Affairs
This position can be based at any AbbVie hub location including: Lake County, IL, Irvine, CA, South San Francisco, CA, Florham Park, NJ.
Responsibilities:
- Perform standard surveillance activities across a product’s life cycle 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 data and lead preparation of materials for ad hoc regulatory safety requests.
- Use medical judgment to assess the impact of safety issues on the product benefit-risk profile; communicate findings to product teams and leadership to support risk minimization (including label changes).
- Prepare and maintain safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plan; independently author and review global aggregate safety reports per regulatory requirements and SOPs.
- Prepare summaries of key safety data for PST, SRB, senior management, Advisory, and similar meetings.
- Apply pharmacovigilance regulations/guidelines and company SOPs; maintain in-depth knowledge of assigned therapeutic areas; mentor and train safety scientists.
Qualifications:
- Degree in a Health Sciences field (e.g., Pharmacy, Epidemiology, Nursing).
- Bachelors + 4 years clinical/pharma or safety work experience.
- Masters/doctorate + 2 years clinical/pharma or safety work experience (e.g., MPH, PharmD, PhD, or Master’s in Health Science).
- Knowledge of drug development process, clinical trials, regulatory submission requirements, product launch, and post-marketing support.
- Understanding of tools/standards/approaches to evaluate drug safety (desired); strong cross-functional, matrix teamwork.
- Effective oral/written communication; ability to manage multiple projects; Microsoft Word/Excel and basic project management; ability to work independently with minimal supervision.
Responsibilities:
- Perform standard surveillance activities across a product’s life cycle 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 data and lead preparation of materials for ad hoc regulatory safety requests.
- Use medical judgment to assess the impact of safety issues on the product benefit-risk profile; communicate findings to product teams and leadership to support risk minimization (including label changes).
- Prepare and maintain safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plan; independently author and review global aggregate safety reports per regulatory requirements and SOPs.
- Prepare summaries of key safety data for PST, SRB, senior management, Advisory, and similar meetings.
- Apply pharmacovigilance regulations/guidelines and company SOPs; maintain in-depth knowledge of assigned therapeutic areas; mentor and train safety scientists.
Qualifications:
- Degree in a Health Sciences field (e.g., Pharmacy, Epidemiology, Nursing).
- Bachelors + 4 years clinical/pharma or safety work experience.
- Masters/doctorate + 2 years clinical/pharma or safety work experience (e.g., MPH, PharmD, PhD, or Master’s in Health Science).
- Knowledge of drug development process, clinical trials, regulatory submission requirements, product launch, and post-marketing support.
- Understanding of tools/standards/approaches to evaluate drug safety (desired); strong cross-functional, matrix teamwork.
- Effective oral/written communication; ability to manage multiple projects; Microsoft Word/Excel and basic project management; ability to work independently with minimal supervision.