Job Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  . Follow @abbvie on  X ,  Facebook ,  Instagram ,  YouTube ,  LinkedIn and  Tik Tok .

Job Description

This position reports Safety Data Architect, Director, in the Decision Sciences in the Pharmacovigilance and Patient Safety (PPS). The PPS organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of Abbvie drugs to protect patients worldwide. The safety data architect is responsible for establishing, documenting, and aligning the life-cycle safety data collection strategy for one or more assigned products in development globally. The incumbent will partner with decision sciences, PPS, clinical development and DSS, providing direction regarding the data collection, aggregation, and analysis and visualization in order to ensure quality, consistency, and guide decision making for the safety of patients for products in development globally.

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, PST TA physician, and safety science leadership in clarifying potential safety concerns.
• Ensures inclusion of safety perspective in study protocols, IND reports, annual reports, and acts as a key driver of updates to Investigator Brochures, Safety sections of the Clinical Reports, Monitoring Plans, and other ad hoc safety reports, as applicable.
• Provides oversight and consistency across an assigned compound(s) and indication(s) for compound safety planning framework, safety risk language, AESIs (adverse events of special interest), frequency of data in aggregate review, and the safety monitoring plan.
• In partnership with PST Lead, PST TA physician, PST PM and Safety Data Sciences, supports the safety issue notification process in order to ensure safety issues and decisions are brought to management and Safety Review Board (SRB).
• 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.

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Frequent to continuous computer usage (greater or equal to 50% of the workday) is required

The role can be remote in the US. 

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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• 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​

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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 an equal opportunity employer and 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.

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