Associate Director, Safety Data Architect (Remote)

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.