Global Medical Director Neuroscience Safety

BioSpace; North Chicago (IL); On-site; USD 150,000 - 230,000; Full time

Job summary

AbbVie in North Chicago, IL seeks a PST Lead to oversee pharmacovigilance activities across one or more products, ensuring that safety surveillance is maintained throughout the product lifecycle. The role requires deep expertise in pharmacology, toxicology and regulatory compliance.

You will lead safety surveillance for pharmaceutical, biological, and drug-device products, develop risk management plans, and supervise DSURs/PSURs while mentoring the safety team and collaborating with

Responsibilities

• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance.
• Responsible for safety surveillance for pharmaceutical / biological / drug –device combination products
• Lead, oversee, and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, risk management plans, periodic safety reports (DSURs, PBRERs/PSURs, PADERs), etc.
• Lead and oversee safety surveillance and pharmacovigilance activities for products in clinical development and marketed products, applying current regulatory guidance as appropriate
• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams and regulatory authorities.
• Effectively and independently write, review, and present technical documents .
• Responsible for implementing risk management strategies for assigned products.
• Proactively engaging, inspiring, coaching and mentoring team and colleagues.

Job description

AbbVie in North Chicago, IL seeks a PST Lead to oversee pharmacovigilance activities across one or more products, ensuring that safety surveillance is maintained throughout the product lifecycle. The role requires deep expertise in pharmacology, toxicology and regulatory compliance.

You will lead safety surveillance for pharmaceutical, biological, and drug-device products, develop risk management plans, and supervise DSURs/PSURs while mentoring the safety team and collaborating with