Medical Director

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

*This role could be based in lake county/ San Francisco or could be remote.

Purpose:
To lead Product Safety Teams (PST) and support one or more products as the PST Lead, ensuring that the safety profile of one or more products is adequately monitored and characterized throughout the product lifecycle (e.g., surveillance, signal detection and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

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.
 

Qualifications

• MD / DO with