Title: Manager, Safety Data Architect
Function: Research & Development
Job Type: Full-time
Job ID: R00121044
Type : Remote
Location: United States
Job Description:
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.
This role can be remote in the US.
Significant Work Activities:
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications
Bachelor's degree with related health science background. RN or clinical pharmacy experience strongly preferred. A minimum of 6 years' experience to include at least 3 years of clinical practice experience and 4 years drug/device safety experience with clinical trial life cycle management - Pre-clinical to Phase III through launch to market.
Proficiency in Computer skills (Windows, Word, Excel) and in specific databases (e.g., oracle/clinical, PIMS, laboratory databases). Ability to lead cross‐functional teams with proven success in results‐driven process management, specifically within clinical trial conduct, operations management for the planning, execution, and reporting of clinical development programs.
Expertise in industry regulations, processes, and clinical safety. Demonstrate excellent interpersonal, leadership, communication and development skills. Ability to establish clear directions/ sets stretching objectives. In depth understanding of product labeling/literature, including safety profile.
Accurately and medically sound presentation of case data, orally and in writing. Strong interpersonal and influencing skills. Ability to manage complex issues and distill information with proven negotiating skills.
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 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.
