Medical Director, Early-Stage Immunology Safety Lead

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

Job summary

AbbVie in Chicago seeks a Product Safety Team Lead to independently manage safety surveillance across one or more early development products, providing medical and strategic leadership to the PV team and guiding safety decisions.

You will integrate pharmacology, toxicology, and clinical data to shape safety strategy, write PV documents, oversee DSURs, and ensure regulatory compliance across trials, with collaboration across cross-functional teams.

Qualifications

• MD / DO with 2+ years of residency with patient management experience.
• Pharmacovigilance experience in the pharmaceutical industry preferred.
• Demonstrated ability to analyze and guide the analysis of preclinical, clinical, and epidemiological data.
• Demonstrated ability to author and critically review technical documents.
• Ability to formulate, clearly present, and defend medical safety assessments and recommendations to cross-functional teams and governance bodies.
• Work collaboratively in a team environment and be self-starting and able to work independently.
• Fluency, both written and oral, in English

Responsibilities

• Serves independently as the Product Safety Team Lead for one or more assigned products in early development, providing medical and strategic leadership to the Product Safety Team and driving evidence-based safety decisions.
• Integrates pharmacology, chemistry, clinical data, and nonclinical toxicology to lead safety surveillance and inform product safety strategy.
• Provides safety oversight for pharmaceutical / biological / drug -device combined investigational products, contributes to the authorship of key pharmacovigilance documents, including but not limited to, development product safety assessments, regulatory responses and risk management plans
• Interprets and applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Leads the analysis and interpretation of safety data and communicates conclusions and recommendations to cross-functional teams and governance bodies.
• Effectively writes, reviews and provides input on technical documents.
• Leads the strategy for Development Safety Update Reports (DSURs)
• Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials
• Leads and implements the risk management strategy for assigned products
• Supports other Product Safety Team Leads and due diligence projects as needed
• Interprets applicable pharmacovigilance regulations to guide patient safety activities and cross-functional safety decision-making.

Skills

Pharmacovigilance

Data analysis

Technical writing

Cross-functional leadership

English fluency

Independent worker

Education

MD/DO

Job description

AbbVie in Chicago seeks a Product Safety Team Lead to independently manage safety surveillance across one or more early development products, providing medical and strategic leadership to the PV team and guiding safety decisions.

You will integrate pharmacology, toxicology, and clinical data to shape safety strategy, write PV documents, oversee DSURs, and ensure regulatory compliance across trials, with collaboration across cross-functional teams.