Associate Director, Safety Data Architect

Purpose:

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.
• Ability to manage direct reports

This role can be remote in the US.

Qualifications :

Qualifications:

• Bachelors 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: 

• 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Yes