Manager, Safety Data Architect
2 weeks ago
This position is part of Safety Data Architect team 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 lead provides strategic and tactical support to the Safety Data Architect and Product Safety Team Lead physician and the Product Safety Team Therapeutic Area physician. The safety data lead is responsible for assisting in summarizing any potential safety concerns observed at the product level from clinical trial data. The safety data lead assists in deliverables for the safety data architect team and independently supports later stage products.
Responsibilities:
• Independently supports later stage products with minimal number of clinical trials or one indication on large, late-stage products. Presents compound safety data for later stage products with minimal number of clinical trials or a therapeutic indication of large, late-stage products within PPS and Clinical Teams or in support of an SDA.
• Assists the safety data architect 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 review of potential safety concerns from clinical trial data. In partnership with the safety data architect 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 when communicating clinical trial data overviews. Applies advanced knowledge of ICH, FDA, EMA regulations and guidelines affecting drug/device safety issues to assigned responsibilities as they impact on CTPS processes, procedures, and global reporting requirements.
• Maintains expertise in CSA processes in order to serve as SME and complete study level reviews for Device products. Understands, implements and improves department SOPs as part of continuous improvement, including implementation of new regulatory requirements.
• Supports CTPS business operations, including but not limited to meeting and project planning, communication planning/alignment and ad hoc project support including project management. Identify areas of improvement in process/policy, develops recommendations/plan and align/maintain effective communication channels with key Clinical, Medical, Regulatory, Compliance, and Pharmacovigilance counterparts.
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
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