AbbVie

Associate Director, Safety Data Architect

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Oct 30, 2020
Ref
2008039
Required Education
Bachelors Degree
Position Type
Full time
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 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.


Qualifications

Basic:

  • 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)
Keyboard use (greater or equal to 50% of the workday)
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.