Safety Data Science Lead, Pharmacovigilance

Allergan; North Chicago (IL); On-site; USD 120,000 - 150,000; Full time

Job summary

AbbVie is seeking a safety-science professional to support the product safety profile across the lifecycle. The role involves signal detection, evaluation, and preparation of summaries for senior management and regulatory authorities globally.

You will collaborate with safety, clinical, and regulatory teams to analyze data from multiple sources, prepare safety documents, and contribute to risk management plans. Strong communication and project management skills are essential.

Qualifications

• Degree in a Health Sciences field (e.g., Pharmacy, Epidemiology, Nursing).
• Experience: 4 years clinical/pharma or safety work (Bachelor level) or 2 years with Masters/PhD.
• Knowledge of drug development, clinical trials, regulatory submission and post-marketing support.
• Regulatory obligations and safety science to support safety decisions.
• Proficiency with safety tools and ability to work in a matrix, multidisciplinary environment.
• Strong written and oral communication; proficient Word/Excel; basic project mgmt; independent worker.

Responsibilities

• Responsible for standard surveillance activities for a product's life cycle by reviewing safety data from trials, safety databases, and literature.
• Collaborates with safety and clinical teams to develop strategies for signal assessments and regulatory requests; analyzes data from multiple sources.
• Uses medical judgment to assess impact of safety issues on benefit-risk; communicates findings to product teams and leadership.
• Prepares and maintains safety sections of Clinical Summary of Safety, CSRs, Company Core Data Sheets, and Risk Management Plans; writes global safety reports.
• Prepares summaries of key safety data for PST, SRB, senior management and other meetings; partners to lead safety initiatives within PPS.
• Mentors and trains new safety scientists; demonstrates regulatory guidelines and SOPs.

Skills

Pharmacovigilance

Cross-functional collaboration

Regulatory awareness

Communication skills

Independent working

Education

Bachelor's degree in Health Sciences

Master's/PhD in Health Sciences

Tools

Microsoft Word

Microsoft Excel

Job description

AbbVie is seeking a safety-science professional to support the product safety profile across the lifecycle. The role involves signal detection, evaluation, and preparation of summaries for senior management and regulatory authorities globally.

You will collaborate with safety, clinical, and regulatory teams to analyze data from multiple sources, prepare safety documents, and contribute to risk management plans. Strong communication and project management skills are essential.