Associate Director, Safety Data Architect

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.

This position reports Safety Data Architect, Director, in Clinical Trial Patient Safety. The PPS organization works collaboratively and strategically with colleagues across the product clinical lifecycle to identify, evaluate, understand and communicate the safety profile of Abbvie drugs to protect patients worldwide. The safety data architect is a strategic partner to the Product Safety Team Lead physician and the Product Safety Team Therapeutic Area physician. The safety data architect is responsible for summarizing any potential safety concerns observed at the product level from clinical trial data. The safety data architect drives consistency across clinical trial protocols through contribution to the safety management plan.

Responsibilities:

• Functions as a driver for data in aggregate to enhance presentation of, or delivery of compound safety within PPS and Clinical Teams.
• Instrumental in coordination of deliverables and meetings to review data in aggregate with the PST Leads and PST TA physicians.
• Proactively utilizes clinical experience and medical knowledge to support the PST Lead and PST TA physician, identifying potential safety concerns from clinical trial data.
• Ensures consistent safety perspective in study protocols, annual reports, and acts as a key driver of updates to Investigator Brochures, Safety Monitoring Plans, and other ad hoc safety reports, as applicable.
• Reviews for consistency across an assigned compound(s) and indication(s) for safety risk language, AESIs (adverse events of special interest), frequency of data in aggregate review, through contributions to the safety monitoring plan.
• In partnership with PST Lead, PST TA physician, and PST PM supports contribution of clinical trial data to regulatory response.
• A strong communicator, ensures alignment, consistency, and data integrity for assigned safety activities. Proactively promotes best practice and knowledge sharing between the PST lead and the PST TA physician to facilitate scientific based discussions and safety decision making.
• Demonstrates ability to connect regulatory obligations and safety science to support safety decision making.

Qualifications

Qualifications:

• Bachelor’s degree in a healthcare discipline (i.e. Life Science, Pharmacy, Nursing or healthcare profession, or biomedical disciplines). Graduate degree preferred. 10 years of experience in clinical research in the pharmaceutical industry.
• Project management experience with cross-functional projects. Knowledge of the drug development process which includes clinical trial conduct, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support.
• Experience in one or more of the following areas: clinical operations management, clinical study management, drug development, risk management, and/or drug safety operations. Understanding tools, standards and approaches to efficiently evaluate drug safety
• Demonstrated effectiveness in working in a multidisciplinary, matrix team environment with the ability to manage change.
• Leadership and communication skills that minimally include: effective and timely communication of project objectives, issues/risks and other project information required to keep the team and management informed.
• Demonstrated sound judgment to manage conflict and negotiations constructively and develop effective working relationships to enable high performing teams.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.