Senior Global Neuroscience Safety Director

American Society for Experimental Neurotherapeutics; Chicago (IL); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Paid time off

Long-term incentive programs

Job summary

AbbVie seeks a pharmacovigilance professional to support the Product Safety Leads and potentially support multiple products under TA leads. The role focuses on surveillance, signal detection, validation and assessment to ensure safety across neuroscience products in trials and post-marketing.

Responsibilities include authorship of PV documents, risk management, and leading regulatory submissions (INDs, NDAs, MAAs) with collaboration across teams. Prior PV experience and MD/DO are required.

Qualifications

• MD/DO with residency and experience in patient management.
• 2–4 years of pharmacovigilance (PV) experience in pharma.
• Ability to analyze clinical data and epidemiological information.
• Ability to present recommendations in group settings.
• Write, review and provide input on technical PV documents.
• Self-starting and able to work independently.
• Collaborative and able to lead cross-functional teams.

Responsibilities

• Apply pharmacology, chemistry and non-clinical toxicology to safety surveillance.
• Safety surveillance for neuroscience products in clinical trials and post-market.
• Authorship of PV documents including safety assessments and risk plans.
• Apply regulatory guidance for PV activities and document authorship.
• Analyze and communicate aggregate safety data to cross-functional teams.
• Write and review technical PV documents.
• Lead safety strategy for regulatory submissions (INDs, NDAs, MAAs, PSURs, PADERs).
• Oversee PV activities for neuroscience products.

Skills

Independent work

Cross-functional collaboration

Regulatory communication

Technical writing

Data interpretation

Education

MD/DO

Residency training

Master Public Health

Job description

AbbVie seeks a pharmacovigilance professional to support the Product Safety Leads and potentially support multiple products under TA leads. The role focuses on surveillance, signal detection, validation and assessment to ensure safety across neuroscience products in trials and post-marketing.

Responsibilities include authorship of PV documents, risk management, and leading regulatory submissions (INDs, NDAs, MAAs) with collaboration across teams. Prior PV experience and MD/DO are required.