Senior Medical Director, Immunology, Global Patient Safety

Responsibilities

• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as needed
• Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission safety component
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Understand the relevant pharmacology, and non-clinical toxicology data
• Effectively write, review and provide input on technical documents independently
• Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)
• Strong team player, able to adapt and work in a fast-paced environment
• Responsible for safety surveillance for pharmaceutical / biological / drug device combined products
• Responsible for implementing risk management strategies for assigned products
• Proactively engage, inspire, coach and mentor team and colleagues
• Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader

Qualifications

• MD / DO with 2+ years of patient management experience required
• 5+ years of patient safety experience in the pharmaceutical industry, including relevant leadership experience
• Prior involvement in marketing authorization application submissions or other relevant regulatory interactions
• Prior experience in pharmaceuticals clinical development
• Immunology/Internal medicine experience is strongly preferred
• 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

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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