Associate Medical Director/Medical Director, Medical Safety Evaluation, Translational Medicine Immunology

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose:

Supporting the Product Safety Leads (PSTLs) and potentially leading one or more products as the PSTL under the direction of the Group Medical Director and Executive Medical Director in ensuring safety through surveillance, signal detection, validation, and assessment. Interpreting regulations related to pharmacovigilance, supporting all patient safety activities.

Responsibilities:

• Understands and applies pharmacology, chemistry, and non-clinical toxicology to effectively conduct safety surveillance

• Conducts safety surveillance for pharmaceutical/biological/drug–device combined products; contributes to the authorship of key pharmacovigilance documents, including but not limited to medical safety assessments, regulatory responses, and risk management plans

 • Applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents

• Analyzes and interprets aggregate safety data and communicates these analyses and interpretations to cross-functional teams

 • Effectively writes, reviews, and provides input on technical documents

• Leads the strategy for periodic reports (DSURs, PSURs, PADERs, etc.)

 • Oversees safety surveillance and pharmacovigilance activities for products in clinical trials

 • Leads and implements risk management strategy for assigned products

Key Stakeholders: Group Medical Director, Executive Director, TA Head, PST Lead, Analytics/Data Scientists, Project Management and Data Management, Clinical Development, Preclinical Safety, Precision Medicine

Qualifications

• MD/DO with 2+ years of residency with patient management experience

• 2–4 years o