Senior Medical Director, Medical Device, Patient Safety

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

Location: Lake County, IL (AbbVie Headquarters) and open to other AbbVie office locations  in the US.

Purpose:

Medical Device Safety Physician leads the safety oversight relevant to her/his assigned products to determine and advise the course of action necessary to meet the safety goals and objectives of specific products and projects. Works in close collaboration with cross-functional teams and counterparts in quality systems, regulatory affairs, medical writing, clinical development, clinical operations, manufacturing, epidemiology, marketing and other functional areas to identify, evaluate, and communicate safety issues.  May contribute relevant clinical safety input to new product design teams as needed. 

The Medical Device Safety Physician is independently responsible for proactive safety strategy, medical safety assessment of SAE/AEs reported to Product Surveillance, clinical study safety management, contribution to post market surveillance activities,  input to compliant regulatory authority reporting, development and implementation of lifecycle safety risk management strategies and communication of safety information for assigned medical device development, clinical studies and marketed products. He/She monitors and manages the ongoing safety profile of products to maximize the understanding of risks and benefits for providers, patients, consumers, study subjects and the environment through proactive review of all relevant pre- and post-marketing safety data, medical analysis and decision making.

Responsibilities:

Device, Combination Products, and InVitro Diagnostics, Clinical Trials- Medical assessment