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Senior Safety Data Scientist
3 months ago
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
The Senior Safety Data Scientist 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:
Responsible for standard surveillance activities for a products life cycle (one or more assigned compounds and products) through review of safety data from clinical trials, safety databases, and the literature.Collaborates with safety and clinical teams to develop strategies and approaches for signal assessments and regulatory requests by analyzing data from multiple sources.Analyzes data to support signal assessment and contributes to ad hoc regulatory safety requests using data from multiple sources with supervision.Utilizes medical judgment to determine the impact of identified safety issues on the compound/ products benefit-risk profile.Communicates findings of surveillance activities and safety assessments to product teams and leadership to inform on necessary risk minimization activities, including label changes.Collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets and Risk Management Plan.Support strategy development, authorship and review of global aggregate safety reports in accordance with regulatory requirements and standard operating procedures with supervision.Prepares summaries of key safety data for PST, SRB, senior management, Advisory and other similar meetings with supervision.Proficient in pharmacovigilance regulations, guidelines, and company standard operating proceduresIn depth understanding of compounds within assigned therapeutic areas, including safety profile and where applicable, labeling, literature, clinical and regulatory issues.Qualifications
Minimum Qualifications:Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing);Bachelors + 2 years clinical/pharma and/or safety work experience ORMasters or doctorate, 1-2 years clinical/pharma and/or safety work experience (e.g. MPH, PharmD, PhD, or Masters in a Health Science)Knowledge 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.Preferred Qualifications:Understanding of tools, standards and approaches used to efficiently evaluate drug safety is desirable, not required.Other Required Skills:Familiar with working in a multidisciplinary, matrix team situationEffective oral and written communication skills with the ability to manage multiple projects simultaneouslyMicrosoft WORD and EXCEL skills and Basic Project Management skillsAble to work independently with guidance from manager
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit
