Associate Director, Medical Device Safety (MD)

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Interpreting device and combination product regulations related to device reporting in support of all patient safety and quality system activities.

Responsibilities:

• Works in close collaboration with cross-functional teams and counterparts in quality systems, regulatory affairs, 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

• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Safety surveillance for pharmaceutical / biological / drug –device combined products
• Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
• Under the guidance of PST Lead write, review and provide input on technical documents

 

 

Key Stakeholders: 

• Device Quality, Manufacturing, Device Regulatory, PST Lead, TA Lead, Analytics / Data Scientists, Project Management and Data Management

 

Qualifications

Qualifications:

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

• Master Public Health and/or Biomedical Engineering is preferred in addition to MD/DO

• Effectively analyze clinical data and epidemiological information required
• Ability to effectively present recommendation / opinions in group environment
•  Effectively write technical documents with direction
•  Self-starting and can work independently
• Work collaboratively in a team environment
• Fluency, both written and oral, in English

Experiences / Leadership traits:

• Ability to work collaboratively with colleagues with different areas of expertise (e.g epidemiology, statistics)
• Ability to work effectively under guidance of more experienced PV colleagues
• Ability to respect other opinions and be inclusive of the different point of views and be open to the ideas of others

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.