Neuroscience Safety Leader - Global Medical Director

Regulatory Toolkit; Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie is seeking a Regulatory Pharmacovigilance professional to support Safety Leads and oversee pharmacovigilance for neuroscience products in trials and post-marketing. You will contribute to safety assessments, risk management plans and regulatory responses, while leading safety strategy for submissions and supervising PV activities with cross-functional teams.

The role requires MD/DO with residency and pharmacovigilance experience; strong analytical and writing skills are essential to

Qualifications

• 2–4 years of Pharmacovigilance experience in the pharmaceutical industry.
• MD/DO with residency and MPH is preferred.
• Ability to analyze clinical data and epidemiology.
• Strong writing and input on PV documents and regulatory submissions.

Responsibilities

• Understand and apply pharmacology, chemistry and non-clinical toxicology for safety surveillance.
• Safety surveillance for neuroscience products in trials and post-marketing.
• Contribute to authorship of PV documents (safety assessments, regulatory responses, risk management plans).
• Lead safety strategy for regulatory submissions (INDs, NDAs, MAAs; PSURs, PADERs).
• Oversee PV activities and cross-functional collaboration.
• Write, review and provide input on technical PV documents.

Education

MD/DO with residency and MPH

Master of Public Health

Job description

AbbVie is seeking a Regulatory Pharmacovigilance professional to support Safety Leads and oversee pharmacovigilance for neuroscience products in trials and post-marketing. You will contribute to safety assessments, risk management plans and regulatory responses, while leading safety strategy for submissions and supervising PV activities with cross-functional teams.

The role requires MD/DO with residency and pharmacovigilance experience; strong analytical and writing skills are essential to