Purpose:

　　The Senior Medical Director will be responsible for one or more pharmaceutical drug products as the Product Safety Team Lead (PSTL). Lead and set strategy for proactive safety surveillance and risk management. Analyze, interpret and present safety data to internal and external stakeholders as needed.

　　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 combined ophthalmic products

　　Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, aggregate safety reports.

　　Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents

　　Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management

　　Independently write, review, and provide input on technical documents

　　Oversight and responsibility for leading the strategy as well as writing, when applicable, the key sections for periodic reports (e.g. DSUR’s, PADER’s and Safety sections of the IBs)

　　Lead and set the strategy, in collaboration with the development medical lead of study protocols and informed consents

　　Responsible for implementing risk management strategies for assigned product

　　Proactively engaging, inspiring, coaching and mentoring team members 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 residency with patient management experience; Experience in ophthalmology is preferred, not required

　　5 - 8 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

　　Key Stakeholders:

　　Global TA Head MSE, PST Lead, TA Lead, Analytics/Data Scientists, Project Management and Data Management

　　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 short-term incentive programs.

　　· 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 employee 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 committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.