Executive Medical Director, Pharmacovigilance and Patient Safety - Immunology - Remote optional

The Executive Medical Director is responsible for the safety strategy for an enterprise leading asset, and to supervise, manage and mentor the MSE staff supporting this asset in the Immunology TA.

Responsibilities: 

• Provides critical oversight of Product Safety Team Leads and other colleagues within MSE in order to set safety strategy for the development programs and lifecycle management of asset.
• Is the MSE representative for asset at AST and the counterpart to the Executive Medical Director for the product on the Clinical Team.
• Interacts with and influences other cross functional departments (e.g. Regulatory Affairs, Medical Affairs), as needed, to ensure the successful development, design and implementation of comprehensive safety assessment to support both study participants in asset development programs and patients on the marketed product.
• May be involved in external communications regarding asset safety.
• Provides strategic input for key safety documents for asset, and may delegate review to respective PST Leads, as appropriate,
• Assures all issued safety documents contain high quality medical safety content and are clearly written.
• Supervises and coordinates with the Product Safety Team Leads the communication of major safety issues for asset across all indications and development programs (as appropriate) to various cross-functional teams.
• Communicates major safety issues for asset to management groups such as the leadership team of RQS, governance bodies such as the Safety Review Board and the Complaint Management Review Board.
• Supervises direct reports in the PST leadership of other products
• Represents MSE in assigned due diligence activities for immunology, and coaches/oversees direct reports in the conduct of such activities
• Coaches and mentors MSE staff and solicit relevant feedback from outside MSE to assist each employee in her/his development and succession planning.
• Drives process improvement and change management in concurrence with companywide and functional plans.
• Drives and advances medical safety capability and capacity both strategically and with innovative approaches.

• MD, DO or equivalent Medical Degree is required.
•  Must have completed a medical residency.
• Direct patient management/ clinical experience beyond residency is preferred.
• Board eligible or Board Certified is preferred.
• Minimum of 5-10 years’ experience in drug safety within the pharmaceutical industry.
• At least 1-2 years’ experience in clinical development is preferred.
• At least two years’ experience in managing people is required.
• Experience in leading multi-disciplinary teams is preferred.

AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.