Medical Director

AbbVie • Mettawa, IL

290d

About The Position

The Medical Director role at AbbVie is focused on leading Product Safety Teams (PST) and supporting one or more products as the PST Lead. The position ensures that the safety profile of products is adequately monitored and characterized throughout the product lifecycle, including surveillance, signal detection and evaluation, and risk management. The role involves interpreting regulations related to pharmacovigilance and supporting all patient safety activities. This position can be based in Lake County, San Francisco, or could be remote.

Requirements

• MD / DO with 2+ years of residency with patient management experience.
• 2-5 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.
• Effectively analyze and guide analysis of clinical data and epidemiological information.
• Effectively present recommendations / opinions in group environment both internally and externally.
• Write, review and provide input on technical documents.
• Work collaboratively and lead cross-functional teams.
• Ability to lead cross-functional teams in a collaborative environment.
• Fluency, both written and oral, in English.
• Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask.

Nice To Haves

• Master Public Health is preferred in addition to MD / DO, not required.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Master's degree