Full Job Description
Purpose: This position partners with cross functional stakeholders in support of the product safety profile and benefit risk throughout product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety to present to senior management and regulatory authorities globally.
Responsibilities:
37Responsible for oversight of surveillance and regulatory activities and deliverables in your designated Therapeutic Area (TA).
37Leads a team of Safety Data Sciences in their role on the Product Safety Team (PST) within a given TA; contributes to the benefit risk evaluation and to safety risk management.
37Provide oversight and actively manages full time employee (safety data scientists) and contract support personnel.
37Key collaborator with Therapeutic Area Heads, safety and clinical physicians and Data and Statistical Sciences to develop strategies for routine and ad hoc safety data analyses.
37Independently authors, strategizes and reviews global aggregate safety reports in accordance with regulatory requirements and standard operating procedures
37Utilizes medical judgment to determine the impact of the safety issue on the product's benefit-risk profile.
37Collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets and Risk Management Plans.
37Assure deliverable alignment to current company standards and global regulations for products/compounds assigned to direct reports.
37Leads safety-related activities/initiatives internal to PPS and with external partners.
37Independently prepares summaries of key safety data for PST, ADT, senior management, Advisory and other similar meetings.
37Trains new safety scientists and mentors established colleagues.
Qualifications
37Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing);
37Bachelors + 7 years clinical/pharma or safety work experience
37Masters or doctorate + 5 years clinical/pharma or safety work experience (e.g. MPH, PharmD, or Masters in a Health Science)
37Knowledge of the drug development process which includes conducting clinical trials, 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.
37Demonstrates ability to connect regulatory obligations and safety science to support safety decision making.
37Understanding of tools, standards and approaches used to efficiently evaluate drug safety.
37Experience in working directly with and influencing senior management including functional heads
37Identifies strengths and weaknesses of team members to further develop their skills through training, mentoring and learning opportunities.
37Optimizes use of team resources and ensures quality and timeliness in team contributions.
37Prior experience with people management desired.
37Identifies new partnerships throughout Abbvie to increase efficiencies
37Initiates strategic plans for deliverables and leads process improvements
37Effective oral and written communication skills with the ability to manage multiple projects simultaneously
37Microsoft WORD and EXCEL skills and Basic Project Management skills
37Able to work independently seeking guidance from manager and PST leads and TA physicians as needed. Able to problem solve and anticipate problems.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
37The 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.
37We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
37This 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.
