Associate Director, Safety Data Sciences
AbbVie
August 20, 2026
On-site
Irvine, CA
$141,500 - $268,500 USD yearly
Operations
This position supports the product safety profile and benefit-risk throughout the product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries for senior management and global regulatory authorities.
Responsibilities
- Perform standard surveillance activities across a product life cycle by reviewing safety data from clinical trials, safety databases, and the literature.
- Collaborate with safety and clinical teams to develop signal assessment strategies and support regulatory requests; independently analyze data and lead preparation of ad hoc regulatory safety request materials.
- Use medical judgment to determine the impact of safety issues on benefit-risk; communicate findings to product teams and leadership to support risk minimization (including label changes).
- Maintain safety content for Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plan; author and review global aggregate safety reports per regulatory requirements and SOPs.
- Prepare key safety-data summaries for PST, SRB, senior management, Advisory, and similar meetings.
- Apply pharmacovigilance regulations, guidelines, and company SOPs; demonstrate in-depth knowledge of assigned therapeutic-area compounds; mentor and train safety scientists.
Qualifications
- Degree in a Health Sciences discipline (e.g., Pharmacy, Epidemiology, Nursing).
- Bachelor’s + 4 years clinical/pharma or safety experience.
- Master’s or doctorate + 2 years clinical/pharma or safety experience (e.g., MPH, PharmD, PhD).
- Knowledge of the drug development process, regulatory requirements, and post-marketing support to connect safety science to decision-making.
- Understanding of tools/standards to evaluate drug safety (desirable).
- Effective oral and written communication; ability to manage multiple projects; Microsoft Word/Excel and basic project management; able to work independently with minimal supervision.
Responsibilities
- Perform standard surveillance activities across a product life cycle by reviewing safety data from clinical trials, safety databases, and the literature.
- Collaborate with safety and clinical teams to develop signal assessment strategies and support regulatory requests; independently analyze data and lead preparation of ad hoc regulatory safety request materials.
- Use medical judgment to determine the impact of safety issues on benefit-risk; communicate findings to product teams and leadership to support risk minimization (including label changes).
- Maintain safety content for Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets, and Risk Management Plan; author and review global aggregate safety reports per regulatory requirements and SOPs.
- Prepare key safety-data summaries for PST, SRB, senior management, Advisory, and similar meetings.
- Apply pharmacovigilance regulations, guidelines, and company SOPs; demonstrate in-depth knowledge of assigned therapeutic-area compounds; mentor and train safety scientists.
Qualifications
- Degree in a Health Sciences discipline (e.g., Pharmacy, Epidemiology, Nursing).
- Bachelor’s + 4 years clinical/pharma or safety experience.
- Master’s or doctorate + 2 years clinical/pharma or safety experience (e.g., MPH, PharmD, PhD).
- Knowledge of the drug development process, regulatory requirements, and post-marketing support to connect safety science to decision-making.
- Understanding of tools/standards to evaluate drug safety (desirable).
- Effective oral and written communication; ability to manage multiple projects; Microsoft Word/Excel and basic project management; able to work independently with minimal supervision.