Associate Director, Safety Data Science: Signals & Risk

Allergan; South San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a pharmacovigilance professional to manage safety signal assessment and regulatory support across the product lifecycle. The role is based at a hub location including South San Francisco, CA, and collaborates with cross-functional teams to prepare safety documentation and present risk insights to senior management.

Responsibilities include surveillance of safety data, regulatory requests, safety report preparation, and contributing to safety sections of key documents.

Qualifications

• Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
• Knowledge of the drug development process and regulatory requirements for safety.
• Understanding of tools and approaches to evaluate drug safety; multidisciplinary collaboration.
• Effective oral and written communication with ability to manage multiple projects.

Responsibilities

• Responsible for standard surveillance activities for a product’s life cycle based on safety data.
• Collaborates with safety and clinical teams to develop signal assessment strategies and regulatory requests.
• Analyzes data for signal assessment and prepares materials for ad hoc regulatory safety requests.
• Communicates findings to product teams and leadership to inform risk minimization activities.
• Prepares safety sections of Clinical Safety documents and Risk Management Plans.
• Mentors and trains new safety scientists.

Skills

Oral and written communication

Independent work

Multitasking across projects

Education

Degree in Health Sciences

Bachelor's degree + 4 years clinical/pharma or safety experience

Masters or Doctorate + 2 years clinical/pharma or safety experience

Tools

Microsoft Word

Excel

Job description

AbbVie is seeking a pharmacovigilance professional to manage safety signal assessment and regulatory support across the product lifecycle. The role is based at a hub location including South San Francisco, CA, and collaborates with cross-functional teams to prepare safety documentation and present risk insights to senior management.

Responsibilities include surveillance of safety data, regulatory requests, safety report preparation, and contributing to safety sections of key documents.