Associate Director, Safety Data Science & Risk Analytics

Biopharma Careers; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

PTO

Medical Insurance

401k

Job summary

AbbVie is seeking a safety scientist to partner with cross-functional teams in support of a product’s safety profile across the lifecycle, including signal detection, evaluation, and summaries for senior management and regulatory authorities globally. The role involves standard surveillance activities, collaboration on signal assessments, and preparation of global safety documents.

A health sciences education plus experience in pharma safety is required, with mentoring responsibilities for

Qualifications

• Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
• Bachelor's + 4 years clinical/pharma or safety work experience.
• Masters or doctorate + 2 years clinical/pharma or safety work experience (e.g. MPH, PharmD, PhD, or Masters in a Health Science)
• Knowledge of drug development process including clinical trials, regulatory requirements, and post-marketing support.
• Understanding of regulatory obligations and safety science to support decision making.

Responsibilities

• Responsible for standard surveillance activities for a product lifecycle through review of safety data.
• Collaborates with safety and clinical teams to develop signal assessment strategies.
• Independently analyzes data for signal assessment and prepares materials for ad hoc regulatory safety requests.
• Utilizes medical judgment to determine impact of safety issues on benefit-risk profile.
• Communicates findings to product teams and leadership for risk minimization activities.

Skills

Health Sciences

Pharmacovigilance

Regulatory knowledge

Communication skills

Education

Health Sciences degree (Pharmacy, Epidemiology, Nursing)

Masters or PhD in Health Science (MPH, PharmD, PhD)

Job description

AbbVie is seeking a safety scientist to partner with cross-functional teams in support of a product’s safety profile across the lifecycle, including signal detection, evaluation, and summaries for senior management and regulatory authorities globally. The role involves standard surveillance activities, collaboration on signal assessments, and preparation of global safety documents.

A health sciences education plus experience in pharma safety is required, with mentoring responsibilities for